Randomized Controlled Trial of the Effect of an Exercise Rehabilitation Program on Symptom Burden in Maintenance Hemodialysis: A Clinical Research Protocol.

Background: People receiving hemodialysis experience high symptom burden that contributes to low functional status and poor health-related quality of life. Management of symptoms is a priority for individuals receiving hemodialysis but limited effective treatments exist. There is emerging evidence that exercise programming can improve several common dialysis-related symptoms. Objective: The primary aim of this study is to evaluate the effect of an exercise rehabilitation program on symptom burden in individuals receiving maintenance hemodialysis. Design: Multicenter, randomized controlled, 1:1 parallel, open label, prospective blinded end point trial. Setting: Three facility-based hemodialysis units in Winnipeg, Manitoba, Canada. Participants: Adults aged 18 years or older with end-stage kidney disease receiving facility-based maintenance hemodialysis for more than 3 months, with at least 1 dialysis-related symptom as indicated by the Dialysis Symptom Index (DSI) severity score >0 (n = 150). Intervention: Supervised 26-week exercise rehabilitation program and 60 minutes of cycling during hemodialysis thrice weekly. Exercise intensity and duration were supervised and individualized by the kinesiologist as per participant baseline physical function with gradual progression over the course of the intervention. Control: Usual hemodialysis care (no exercise program). Measurements: Our primary outcome is change in symptom burden at 12 weeks as measured by the DSI severity score. Secondary outcomes include change in modified DSI severity score (includes 10 symptoms most plausible to improve with exercise), change in DSI severity score at 26 and 52 weeks; time to recover post-hemodialysis; health-related quality of life measured using EuroQol (EQ)-5D-5L; physical activity behavior measured by self-report (Godin-Shepherd questionnaire) and triaxial accelerometry; exercise capacity (shuttle walk test); frailty (Fried); self-efficacy for exercise; and 1-year hospitalization and mortality. Methods: Change in primary outcome will be compared between groups by independent 2-tailed t test or Mann-Whitney U test depending on data distribution and using generalized linear mixed models, with study time point as a random effect and adjusted for baseline DSI score. Similarly, change in secondary outcomes will be compared between groups over time using appropriate parametric and nonparametric statistical tests depending on data type and distribution. Limitations: The COVID-19 pandemic restrictions on clinical research at our institution delayed completion of target recruitment and prevented collection of accelerometry and physical function outcome data for 15 months until restrictions were lifted. Conclusions: The application of an exercise rehabilitation program to improve symptom burden in individuals on hemodialysis may ameliorate common symptoms observed in individuals on hemodialysis and result in improved quality of life and reduced disability and morbidity over the long term. Importantly, this pragmatic study, with a standardized exercise intervention that is adaptable to baseline physical function, addresses an important gap in both clinical care of hemodialysis patients and our current knowledge.

Contexte: Les personnes sous hémodialyse éprouvent un grand nombre de symptômes qui contribuent à un faible état fonctionnel et à une mauvaise qualité de vie liée à la santé. La prise en charge des symptômes est une priorité pour les personnes sous hémodialyse, mais les traitements efficaces sont limités. De nouvelles preuves montrent que l'adoption d'un programme d'exercice permettrait d'améliorer plusieurs symptômes courants liés à la dialyse. Objectifs: Le principal objectif de cette étude est d'évaluer l'effet d'un programme de rééducation par l'exercice sur le fardeau des symptômes chez les personnes recevant une hémodialyse d'entretien. Conception: Essai clinique prospectif randomisé-contrôlé, en aveugle, en parallèle 1:1 et ouvert, multicentrique. Cadre: Trois unités d'hémodialyse de Winnipeg, au Manitoba (Canada). Sujets: Des adultes atteints d'insuffisance rénale terminale qui reçoivent des traitements d'hémodialyse d'entretien en centre depuis plus de trois mois et qui présentent au moins un symptôme lié à la dialyse, tel qu'indiqué par un score de gravité de l'indice des symptômes de la dialyse (Dialysis Symptom Index) supérieur à zéro (n = 150). Intervention: Programme supervisé de rééducation par l'exercice d'une durée de 26 semaines et 60 minutes de vélo trois fois par semaine pendant l'hémodialyse. L'intensité et la durée de l'exercice ont été supervisées par un kinésiologue qui les a ensuite personnalisées en fonction de la forme physique initiale du participant en prévoyant une progression graduelle tout au long de l'intervention. Groupe témoin: Soins habituels d'hémodialyse (sans programme d'exercice). Mesures: Notre principal critère de jugement est un changement dans le fardeau lié aux symptômes après 12 semaines, tel que mesuré par le score de gravité de l'indice des symptômes de dialyse (ISD). Les critères d'évaluation secondaires comprennent un changement du score modifié de gravité de l'ISD (portant sur 10 symptômes les plus plausibles de s'améliorer avec l'exercice), la modification du score de gravité de l'ISD après 26 et 52 semaines, le temps de récupération après l'hémodialyse, la qualité de vie liée à la santé mesurée par le questionnaire EQ5D-5L, le comportement lié à l'activité physique mesuré par autoévaluation (questionnaire Godin-Shepherd) et par accéléromètre triaxial, la capacité d'effort (test de marche navette), la fragilité (Fried), le sentiment d'efficacité autodéclaré face à l'exercice, ainsi que les hospitalisations et la mortalité à un an. Méthodologie: Les changements pour le principal critère de jugement seront comparés entre les groupes par un test t bilatéral indépendant ou un test U de Mann-Whitney en fonction de la distribution des données, ainsi qu'à l'aide de modèles linéaires mixtes généralisés avec un point temporel de l'étude comme effet aléatoire et corrigé en fonction du score ISD initial. Les changements dans les résultats secondaires seront comparés entre les groupes au fil du temps à l'aide des tests statistiques paramétriques et non paramétriques appropriés selon le type de données et la distribution. Limites: Les restrictions liées à la pandémie de COVID-19 dans notre établissement ont retardé le recrutement des cibles et empêché pendant 15 mois la collecte de données sur les résultats mesurés par l'accéléromètre et les mesures de la fonction physique, soit jusqu'à ce que les restrictions soient levées. Conclusion: L'adoption d'un programme de rééducation par l'exercice visant à réduire le fardeau lié aux symptômes chez les personnes sous hémodialyse peut améliorer les symptômes courants observés dans cette population et se traduire par une amélioration de la qualité de vie et une réduction de l'invalidité et de la morbidité à long terme. Il convient de noter que cet essai pragmatique, avec son intervention d'exercice standardisée adaptable à la condition physique initiale de la personne, comble une lacune importante dans les soins cliniques des patients sous hémodialyse et dans nos connaissances actuelles.

A Higher Concentration of Dialysate Magnesium to Reduce the Frequency of Muscle Cramps: A Narrative Review.

PURPOSE OF REVIEW: Strategies to mitigate muscle cramps are a top research priority for patients receiving hemodialysis. As hypomagnesemia is a possible risk factor for cramping, we reviewed the literature to better understand the physiology of cramping as well as the epidemiology of hypomagnesemia and muscle cramps. We also sought to review the evidence from interventional studies on the effect of oral and dialysate magnesium-based therapies on muscle cramps. SOURCES OF INFORMATION: Peer-reviewed articles. METHODS: We searched for relevant articles in major bibliographic databases including MEDLINE and EMBASE. The methodological quality of interventional studies was assessed using a modified version of the Downs and Blacks criteria checklist. KEY FINDINGS: The etiology of muscle cramps in patients receiving hemodialysis is poorly understood and there are no clear evidence-based prevention or treatment strategies. Several factors may play a role including a low concentration of serum magnesium. The prevalence of hypomagnesemia (concentration of <0.7 mmol/L) in patients receiving hemodialysis ranges from 10% to 20%. Causes of hypomagnesemia include a low dietary intake of magnesium, use of medications that inhibit magnesium absorption (eg, proton pump inhibitors), increased magnesium excretion (eg, high-dose loop diuretics), and a low concentration of dialysate magnesium. Dialysate magnesium concentrations of ≤0.5 mmol/L may be associated with a decrease in serum magnesium concentration over time. Preliminary evidence from observational and interventional studies suggests a higher dialysate magnesium concentration will raise serum magnesium concentrations and may reduce the frequency and severity of muscle cramps. However, the quality of evidence supporting this benefit is limited, and larger, multicenter clinical trials are needed to further determine if magnesium-based therapy can reduce muscle cramps in patients receiving hemodialysis. In studies conducted to date, increasing the concentration of dialysate magnesium appears to be well-tolerated and is associated with a low risk of symptomatic hypermagnesemia. LIMITATIONS: Few interventional studies have examined the effect of magnesium-based therapy on muscle cramps in patients receiving hemodialysis and most were nonrandomized, pre-post study designs.

CONTEXTE MOTIVANT LA REVUE: Les stratégies visant à atténuer les crampes musculaires sont parmi les principales priorités de recherche des patients hémodialysés. L'hypomagnésémie étant un possible facteur de risque, nous avons procédé à une revue de la littérature afin de mieux en comprendre l'épidémiologie, et d'examiner la physiologie et l'épidémiologie des crampes musculaires. Nous souhaitions également examiner les données probantes issues d'études interventionnelles portant sur l'effet des thérapies à base de dialysat de magnésium et de magnésium oral sur les crampes musculaires. SOURCES: Articles examinés par les pairs. MÉTHODOLOGIE: Nous avons cherché les articles pertinents dans les principales bases de données bibliographiques, notamment MEDLINE et EMBASE. La qualité méthodologique a été évaluée à l'aide d'une version modifiée des critères de contrôle de la qualité des études de Downs et Black. PRINCIPAUX RÉSULTATS: L'étiologie des crampes musculaires chez les patients hémodialysés est mal comprise et il n'existe aucune stratégie de prévention ou traitement clairement fondé sur des données probantes. Plusieurs facteurs pourraient jouer un rôle, notamment de faibles concentrations sériques de magnésium. La prévalence de l'hypomagnésémie (concentration inférieure à 0,7 mmol/L) chez les patients hémodialysés variait de 10 à 20 %. Une faible consommation de magnésium dans l'alimentation, la prise de médicaments inhibant l'absorption du magnésium (ex. les inhibiteurs de la pompe à protons), l'excrétion accrue du magnésium (ex. dose élevée de diurétiques de l'anse) et une faible concentration de dialysat de magnésium figuraient parmi les causes d'hypomagnésémie. Un taux de dialysat de magnésium inférieur ou égal à 0,5 mmol/L pourrait être associé à une diminution de la concentration sérique de magnésium au fil du temps. Les résultats préliminaires de certaines études observationnelles et interventionnelles suggèrent qu'une concentration sérique plus élevée de magnésium dans le dialysat augmenterait les concentrations sériques de magnésium et pourrait réduire la fréquence et la sévérité des épisodes de crampes musculaires. La qualité des preuves appuyant ce bienfait est cependant limitée. Des essais multicentriques et à plus vaste échelle sont nécessaires pour juger si un traitement à base de magnésium peut véritablement réduire les crampes musculaires chez les patients hémodialysés. Dans les études menées jusqu'à maintenant, l'augmentation de la concentration de dialysat de magnésium semblait bien tolérée et a été associée à un faible risque d'hypermagnésémie symptomatique. LIMITES: Peu d'études interventionnelles ont examiné l'effet de la prise de magnésium sur les crampes musculaires des patients hémodialysés, et la plupart de celles-ci constituaient des plans pré- ou post-études non randomisées.

Is Assisted Peritoneal Dialysis a Solution for Northern Manitoba?

Background: End-stage kidney disease (ESKD) continues to fundamentally impact the lives of First Nations (FN) patients. Home peritoneal dialysis (PD) offers patients more mobility and flexibility, but few Manitoba FNs have availed themselves of this option. Objective: This paper discusses Manitoba FNs' experience of PD, to highlight enablers and barriers to expanding the use of PD in rural and remote Manitoba communities. Methods: We analyzed interviews of individuals living with ESKD (N = 14), family caregivers (N = 14) and healthcare providers and administrators (N = 27). Results: Barriers to PD uptake include medical suitability, patients' distrust of home modalities and fear in their ability to manage. Other factors include limited family support and lack of appropriate housing. Conclusions: Assisted peritoneal dialysis (APD) is an emerging model where PD supplies are centrally located, and where a cohort of PD patients can provide mutual support with added assistance from an APD worker. This model could mitigate existing treatment barriers.

Assessing Symptoms, Concerns, and Quality of Life in Noncancer Patients at End of Life: How Concordant Are Patients and Family Proxy Members?

CONTEXT: It has become commonplace to use family caregivers as proxy responders where patients are unable to provide information about their symptoms and concerns to health care providers. OBJECTIVES: The objective of this study was to determine the degree of concordance between patients' and family members' reports of patient symptoms and concerns at end of life. METHODS: Sample dyads included a mix of patients residing at home, in a nursing home, in a long-term care facility, or in hospice. Diagnoses included patients with amyotrophic lateral sclerosis (n = 75), chronic obstructive pulmonary disease (n = 52), end-stage renal disease (n = 42), and institutionalized, cognitively intact frail elderly (n = 49). Dyads completed the Patient Dignity Inventory (PDI), the modified Structured Interview Assessment of Symptoms and Concerns in Palliative Care, and Graham and Longman's two-item Quality of Life Scale. RESULTS: Concordance was less than 70% for seven of the 25 PDI items, with the lowest concordance (65.1%) for the item "not being able to continue with my usual routines." For all but one PDI item, discordance was in the direction of family members reporting that the patient was worse off than the patient had indicated. Where discordance was observed on the Structured Interview Assessment of Symptoms and Concerns in Palliative Care and Quality of Life Scales, the trend toward family members overreporting patient distress and poor quality of life continued. CONCLUSION: Understanding discordance between patients and family member reports of symptoms and concerns is a valuable step toward minimizing patient and family burden at end of life.

Patterns of emergency department utilization by patients on chronic dialysis: A population-based study.

IMPORTANCE: Patients on dialysis are often elderly and frail, with multiple comorbid conditions, and are heavy users of Emergency Department (ED) services. However, objective data on the frequency and pattern of ED utilization by dialysis patients are sparse. Such data could identify periods of highest risk for ED visits and inform health systems interventions to mitigate these risks and improve outcomes. OBJECTIVE: To describe the pattern and frequency of presentation to ER by dialysis patients. DESIGN: Retrospective cohort study using administrative data collected over ten years (2000-2009) in the Province of Manitoba, Canada. SETTING: Patients presenting to any of 9 ED's in Winnipeg and Brandon Manitoba. These departments serve >90% of the population of Manitoba, Canada (population 1.2 million). PARTICIPANTS: All patients presenting to an ED in any of 9 emergency departments in Manitoba, Canada. EXPOSURE: Dialysis status. MAIN OUTCOMES: Presentation to the ED. RESULTS: Over 2.1 million ED visits by more than 1.2 million non-dialysis patients and 17,782 ED visits by 3257 dialysis patients were included. Dialysis patients presented 8.5 times more frequently to the ED than the general population (age and sex adjusted, p<0.001). For dialysis patients, ED utilization was significantly higher following the long interdialytic interval (33.6% higher Mondays and 19.5% higher Tuesdays vs. other days of the week, p<0.001) and was 10-fold higher in the 7 days before and after the initiation of dialysis. CONCLUSION AND RELEVANCE: The heavy use of ED services by dialysis patients spikes upward following the long interdialytic interval and also in the week before and after dialysis initiation. The relative risks associated with these vulnerable periods were much higher than those reported for clinical patient characteristics. We propose that intrinsic gaps in the structure of care delivery (e.g. 3 times a week dialysis, imperfect surveillance and clinical monitoring of patients with low GFR) may be the fundamental drivers of this periodicity. Strategies to mitigate this excess health risk are needed.

Association between Duration of Predialysis Care and Mortality after Dialysis Start.

BACKGROUND AND OBJECTIVES: Early nephrology referral is recommended for people with CKD on the basis of observational studies showing that longer nephrology care before dialysis start (predialysis care) is associated with lower mortality after dialysis start. This association may be observed because predialysis care truly reduces mortality or because healthier people with an uncomplicated course of disease will have both longer predialysis care and lower risk for death. We examined whether the survival benefit of longer predialysis care exists after accounting for the potential confounding effect of disease course that may also be affected by predialysis care. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We performed a retrospective cohort study and used data from 3152 adults with end stage kidney failure starting dialysis between 2004 and 2014 in five Canadian dialysis programs. We obtained duration of predialysis care from the earliest nephrology outpatient visit to dialysis start; markers of disease course, including inpatient or outpatient dialysis start and residual kidney function around dialysis start; and all-cause mortality after dialysis start. RESULTS: The percentages of participants with 0, 1-119, 120-364, and ≥365 days of predialysis care were 23%, 8%, 10%, and 59%, respectively. When we ignored markers of disease course as in previous studies, longer predialysis care was associated with lower mortality (hazard ratio120-364 versus 0-119 days, 0.60; 95% confidence interval, 0.46 to 0.78]; hazard ratio≥365 versus 0-119 days, 0.60; 95% confidence interval, 0.51 to 0.71; standard Cox model adjusted for demographics and laboratory and clinical characteristics). When we additionally accounted for markers of disease course using the inverse probability of treatment weighted Cox model, this association was weaker and no longer significant (hazard ratio120-364 versus 0-119 days, 0.84; 95% confidence interval, 0.60 to 1.18; hazard ratio≥365 versus 0-119 days, 0.88; 95% confidence interval, 0.69 to 1.13). CONCLUSIONS: The association between longer predialysis care and lower mortality after dialysis start is weaker and imprecise after accounting for patients' course of disease.

Correction: Dignity and Distress towards the End of Life across Four Non-Cancer Populations.

[This corrects the article DOI: 10.1371/journal.pone.0147607.].

Dignity and Distress towards the End of Life across Four Non-Cancer Populations.

OBJECTIVE: The purpose of this study was to identify four non-cancer populations that might benefit from a palliative approach; and describe and compare the prevalence and patterns of dignity related distress across these diverse clinical populations. DESIGN: A prospective, multi-site approach was used. SETTING: Outpatient clinics, inpatient facilities or personal care homes, located in Winnipeg, Manitoba and Edmonton, Alberta, Canada. PARTICIPANTS: Patients with advanced Amyotrophic Lateral Sclerosis (ALS), Chronic Obstructive Pulmonary Disease (COPD), End Stage Renal Disease (ESRD); and the institutionalized alert frail elderly. MAIN OUTCOME MEASURE: In addition to standardized measures of physical, psychological and spiritual aspects of patient experience, the Patient Dignity Inventory (PDI). RESULTS: Between February 2009 and December 2012, 404 participants were recruited (ALS, 101; COPD, 100; ESRD, 101; and frail elderly, 102). Depending on group designation, 35% to 58% died within one year of taking part in the study. While moderate to severe loss of sense of dignity did not differ significantly across the four study populations (4-11%), the number of PDI items reported as problematic was significantly different i.e. ALS 6.2 (5.2), COPD 5.6 (5.9), frail elderly 3.0 (4.4) and ESRD 2.3 (3.9) [p < .0001]. Each of the study populations also revealed unique and distinct patterns of physical, psychological and existential distress. CONCLUSION: People with ALS, COPD, ESRD and the frail elderly face unique challenges as they move towards the end of life. Knowing the intricacies of distress and how they differ across these groups broadens our understanding of end-of-life experience within non-cancer populations and how best to meet their palliative care needs.

An ethanol/sodium citrate locking solution compared to heparin to prevent hemodialysis catheter-related infections: a randomized pilot study.

PURPOSE: The objective of this study was to compare the initial safety and efficacy of a novel 30% ethanol/4% sodium citrate catheter-locking solution to heparin in a hemodialysis population. METHODS: This was a prospective, randomized, pilot study of 40 hemodialysis patients randomized to a 30% ethanol/4% sodium citrate or heparin 1000 units/mL locking solution. The primary outcome was identification of any serious adverse events over the study duration. Secondary outcomes included the rate per 1000 catheter days for catheter-related bloodstream infections (CRBSI), alteplase use, catheter dysfunction, and catheter removal. RESULTS: Three serious adverse events were reported as possibly related to the catheter solutions. Only one CRBSI was observed during the study in the heparin arm. The rate of alteplase use was 1.5/1000 catheter days in the heparin arm compared to 2.8/1000 catheter days in the ethanol/citrate arm (rate ratio = 1.85, 90% CI 0.48, 7.07, p value = 0.45), while the rate of catheter dysfunction was 6.8/1000 catheter days in the heparin arm compared to 1.9/1000 catheter days in the ethanol citrate arm (rate ratio = 0.27, 90% CI 0.10, 0.74, p value = 0.04). Catheter survival to first catheter outcome was longer in the ethanol/citrate group compared to heparin and there were no catheter removals due to bacteremia or thrombosis. CONCLUSIONS: The ethanol/sodium citrate locking solution was safely used in this study. It appears to prevent CRBSI and may improve catheter survival compared to heparin. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01394458.

An Economic Assessment Model of Rural and Remote Satellite Hemodialysis Units.

BACKGROUND: Kidney Failure is epidemic in many remote communities in Canada. In-centre hemodialysis is provided within these settings in satellite hemodialysis units. The key cost drivers of this program have not been fully described. Such information is important in informing the design of programs aimed at optimizing efficiency in providing dialysis and preventative chronic kidney disease care in remote communities. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: We constructed a cost model based on data derived from 16 of Manitoba, Canada's remote satellite units. We included all costs for operation of the unit, transportation, treatment, and capital costs. All costs were presented in 2013 Canadian dollars. RESULTS: The annual per-patient cost of providing hemodialysis in the satellite units ranged from $80,372 to $215,918 per patient, per year. The median per patient, per year cost was $99,888 (IQR $89,057-$122,640). Primary cost drivers were capital costs related to construction, human resource expenses, and expenses for return to tertiary care centres for health care. Costs related to transport considerably increased estimates in units that required plane or helicopter transfers. CONCLUSIONS: Satellite hemodialysis units in remote areas are more expensive on a per-patient basis than hospital hemodialysis and satellite hemodialysis available in urban areas. In some rural, remote locations, better value for money may reside in local surveillance and prevention programs in addition support for home dialysis therapies over construction of new satellite hemodialysis units.

Impact of modality choice on rates of hospitalization in patients eligible for both peritoneal dialysis and hemodialysis.

BACKGROUND: Hospitalization rates are a relevant consideration when choosing or recommending a dialysis modality. Previous comparisons of peritoneal dialysis (PD) and hemodialysis (HD) have not been restricted to individuals who were eligible for both therapies. ♢ METHODS: We conducted a multicenter prospective cohort study of people 18 years of age and older who were eligible for both PD and HD, and who started outpatient dialysis between 2007 and 2010 in four Canadian dialysis programs. Zero-inflated negative binomial models, adjusted for baseline patient characteristics, were used to examine the association between modality choice and rates of hospitalization. ♢ RESULTS: The study enrolled 314 patients. A trend in the HD group toward higher rates of hospitalization, observed in the primary analysis, became significant when modality was treated as a time-varying exposure or when the population was restricted to elective outpatient starts in patients with at least 4 months of pre-dialysis care. Cardiovascular disease, infectious complications, and elective surgery were the most common reasons for hospital admission; only 23% of hospital stays were directly related to complications of dialysis or kidney disease. ♢ CONCLUSIONS: Efforts to promote PD utilization are unlikely to result in increased rates of hospitalization, and efforts to reduce hospital admissions should focus on potentially avoidable causes of cardiovascular disease and infectious complications.

Effect of a preventive foot care program on lower extremity complications in diabetic patients with end-stage renal disease.

BACKGROUND: Lower extremity complications are a major cause of morbidity and mortality in patients with end-stage renal disease (ESRD) and diabetes mellitus. Patient education programs may decrease the risk of diabetic foot complications. METHODS: A preventive program was instituted, consisting of regular assessments by a foot care nurse with expertise in foot care and wound management and patient education about foot care practices and footwear selection. Medical records were reviewed and patients were examined. A comparison was made with data about patients from a previous study done from this institution prior to development of the foot care program. RESULTS: Diabetic subjects more frequently had weakness of the left tibialis anterior, left tibialis posterior, and left peroneal muscles than non-diabetic subjects. A smaller percentage of diabetic subjects had sensory neuropathy compared with the previous study from 5years earlier, but a greater percentage of diabetic subjects had absent pedal pulses in the current study. The frequency of inadequate or poor quality footwear was less in the current study compared with the previous study. CONCLUSIONS: The current data suggest that a foot care program consisting of nursing assessments and patient education may be associated with a decrease in frequency of neuropathy and improved footwear adequacy in diabetic patients with ESRD.

Alteplase for blood flow restoration in hemodialysis catheters: a multicenter, randomized, prospective study comparing "dwell" versus "push" administration.

AIMS: Catheter-related thrombosis is a frequent complication of providing hemodialysis via central venous catheters. The primary aim of this study was to compare the efficacy of an alteplase "dwell" protocol over 30 minutes (with an additional 90 minutes where necessary) to a new 30 minute "push" protocol in restoring function to occluded hemodialysis catheters. METHODS: This was a prospective, randomized, parallel arm, multicenter study. Participants included hemodialysis patients using central venous catheters for vascular access. A new alteplase push protocol was the intervention and was compared to an alteplase dwell protocol. The primary outcome of this study was the proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a post thrombolytic blood flow ≥ 300 ml/ min. Secondary outcomes included recovery of Kt/V and liters processed per hour at the hemodialysis session following the intervention, time from thrombolytic to future catheter interventions, and the presence of serious adverse events. RESULTS: 82 patients were included in the intention-to-treat analysis. 65% (28/43) of catheters receiving the dwell protocol achieved blood flow ≥ 300 ml/min compared to 82% (32/39) in the push protocol. The difference was not statistically significant despite a 17% separation in the point estimates, p = 0.84. A non-significant result may have been associated with an inability to enrol the required a priori sample size. Kt/V, liters processed per hour and time to next catheter event were not significantly different. There were no serious adverse events attributed to the study medication. CONCLUSIONS: The alteplase push protocol was effective and safe for managing dysfunctional hemodialysis catheters and was more practical than a 2 h dwell.

Prevalence, risk factors and awareness of albuminuria on a Canadian First Nation: a community-based screening study.

BACKGROUND: Both diabetic and non-diabetic end stage renal disease (ESRD) are more common among Canadian First Nations people than among the general Canadian population. The purpose of this research was to determine the prevalence of and risk factors for albuminuria in a Canadian First Nation population at high risk for ESRD and dialysis. METHODS: Data from a community-based screening study of 483 residents of a Plains Ojibway First Nation in Manitoba was used. Participants provided random urine samples. Proteinuria was defined as any dipstick positive for protein (≥1 g/L) or those with ACR in the macroalbuminuric range (≥30 mg/mmol) on at least one sample. Microalbuminuria was defined as ACR ≥2 mg/mmol for males and ≥2.8 mg/mmol for females. Other measures included fasting glucose, haemoglobin A1c, triglycerides, cholesterol, blood pressure, height, weight and waist and hip circumferences. RESULTS: Twenty percent of study participants had albuminuria, (5% proteinuria and 15% microalbuminuria). Of participants with diabetes, 42% (56/132) had albuminuria compared to 26% (7/27) among those with impaired fasting glucose and 10% (30/303) among those with normal glucose tolerance. Only 5.3% of those with albuminuria were aware of any degree of renal disease. In a multivariate logistic regression, independent associations with albuminuria were male gender [p = 0.002], increasing fasting glucose [p <0.0001], years diagnosed with diabetes [p = 0.03], increasing systolic blood pressure [p = 0.009], and increasing body mass index (BMI) [p = 0.04]. CONCLUSIONS: The independent association between BMI and albuminuria has not been previously reported among indigenous populations. There is a high prevalence of albuminuria in this Canadian First Nation population; the high proportion of patients with diabetes and undiagnosed kidney disease demonstrates the need for screening, education and intervention to halt the progression and development of albuminuria and ultimately ESRD and CVD.

Choosing peritoneal dialysis reduces the risk of invasive access interventions.

BACKGROUND: Patients choosing between hemodialysis (HD) and peritoneal dialysis (PD) should be well informed of the risks and benefits of each modality. Invasive access interventions are important outcomes because frequent interventions lower patient's quality of life and consume limited resources. The objective of this study was to compare the risk of access interventions between the two modalities. METHODS: Three hundred and sixty-nine incident chronic dialysis patients were prospectively enrolled at four Canadian centers that were eligible for both modalities, received at least 4 months of pre-dialysis care and started dialysis electively as an outpatient. Two hundred and twenty-four (61%) chose PD and 145 (39%) chose HD. Patients were followed for an average of 1.3 years (range 0.07-3.6 years). RESULTS: In the PD group, there were fewer access interventions (2.5 versus 3.1 interventions per patient, adjusted odds ratio of 0.79 for PD versus HD, P = 0.005) and a lower intervention rate (2.3 versus 1.9 per patient-year, adjusted rate ratio of 0.81 for PD versus HD, P = 0.04). PD catheters were less likely to experience primary failure (4.6 versus 32%, P < 0.0001), showed a trend toward lower intervention rates during use (0.8 versus 1.2 per patient-year, P = 0.06), and had equal patency compared to fistulae (1-year patency of 84 versus 88%, P = 0.48). Patients managed exclusively with HD catheters (28% of the HD group) required 1.7 interventions per patient and an intervention rate of 1.9 per patient-year. CONCLUSION: Patients who choose PD require fewer access interventions to maintain dialysis access than patients choosing HD.

Home hemodialysis in the remote Canadian north: treatment in Manitoba fly-in communities.

Manitoba has the highest prevalence of ESRD in Canada. Northern Manitoba is a very sparsely settled area with a high proportion of aboriginal ESRD patients. Relocating to urban areas for dialysis is psychosocially and culturally stressful to patients. Delivering dialysis care in a home setting has demonstrated advantages in both clinical, economic, and health related quality of life domains. Establishing home hemodialysis in very remote communities has significant challenges, including poor and inadequate housing, unreliable water supply, limited community medical backup, and poor road access to communities especially for delivery of supplies. These challenges necessitate the development of strong community partnerships, and well documented processes for contingencies. A dedicated interdisciplinary support and training team at the urban hub is essential.

Obesity and obesity-related comorbidities in a Canadian First Nation population.

INTRODUCTION: Rates of obesity are higher among Canada's Aboriginal First Nations populations than among non-First Nations populations. We studied obesity and obesity-related illness in a Manitoba First Nation community. METHODS: We conducted a screening study of diabetes and diabetes complications in 2003, from which we drew a representative sample of Manitoba First Nations adults (N = 483). We assessed chronic disease and chronic disease risk factors. RESULTS: Prevalence of obesity and associated comorbidities was higher among women than men. By using multivariate analysis, we found that factors significantly associated with obesity among women were diastolic blood pressure, insulin resistance, and employment status. Among men, factors were age, apolipoprotein A1 level, apolipoprotein B level, and insulin resistance. Seventy-five percent of study participants had at least 1 of the following conditions: obesity, dyslipidemia, hypertension, or diabetes. Comorbidity was high even among the youngest age groups; 22% of men and 43% of women aged 18 to 29 had 2 or more chronic conditions. Twenty-two percent of participants had undiagnosed hypertension. Participants with undiagnosed hypertension had significantly more chronic conditions and were more likely to have microalbuminuria than were those without hypertension. The number of chronic conditions was not significantly different for participants with newly diagnosed hypertension than for those with previously diagnosed hypertension. CONCLUSION: The prevalence of obesity and other chronic conditions in the study community is high, especially considering the number of young people. Community-based interventions are being undertaken to reduce the excessive rate of illness.

Upper extremity complications in patients with chronic renal failure receiving haemodialysis.

Limited data are available about disability associated with upper extremity complications in patients who receive haemodialysis for end-stage renal disease. In this study of 123 patients receiving haemodialysis, the mean Disabilities of the Arm, Shoulder and Hand (DASH) score was 31 ± 22 points, indicating markedly greater disability than in a normal population. Dupuytren's contracture was the most frequent deformity. Brachial, radial and ulnar pulses were present in most upper limbs, but 14 (14%) of 102 patients had poor arterial perfusion pressures. Diabetic patients had residual or complete loss of protective sensation more frequently than nondiabetic patients. Motor testing with the index finger abduction and fifth finger flexion tests showed a significantly greater frequency of weakness in diabetic than nondiabetic patients. In summary, upper extremity disability was noted in haemodialysis patients, including loss of protective sensation and motor strength, both in diabetic and nondiabetic subjects.

Impact of contraindications, barriers to self-care and support on incident peritoneal dialysis utilization.

BACKGROUND: Targets for peritoneal dialysis (PD) utilization may be difficult to achieve because many older patients have contraindications to PD or barriers to self-care. The objectives of this study were to determine the impact that contraindications and barriers to self-care have on incident PD use, and to determine whether family support increased PD utilization when home care support is available. METHODS: Consecutive incident dialysis patients were assessed for PD eligibility, offered PD if eligible and followed up for PD use. All patients lived in regions where home care assistance was available. RESULTS: The average patient age was 66 years. One hundred and ten (22%) of the 497 patients had absolute medical or social contraindications to PD. Of the remaining 387 patients who were potentially eligible for PD, 245 (63%) had at least one physical or cognitive barrier to self-care PD. Patients with barriers were older, weighed less and were more likely to be female, start dialysis as an inpatient and have a history of vascular disease, cardiac disease and cancer. Family support was associated with an increase in PD eligibility from 63% to 80% (P = 0.003) and PD choice from 40% to 57% (P = 0.03) in patients with barriers to self-care. Family support increased incidence PD utilization from 23% to 39% among patients with barriers to self-care (P = 0.009). When family support was available, 34% received family-assisted PD, 47% received home care-assisted PD, 12% received both family- and home care-assisted PD, and 7% performed only self-care PD. Incident PD use in an incident end-stage renal disease (ESRD) population was 30% (147 of the 497 patients). CONCLUSIONS: Contraindications, barriers to self-care and the availability of family support are important drivers of PD utilization in the incident ESRD population even when home assistance is available. These factors should be considered when setting targets for PD.

Model for equitable care and outcomes for remote full care hemodialysis units.

BACKGROUND AND OBJECTIVES: Remotely located patients not living close to a nephrologist present major challenges for providing care. Various models of remotely delivered care have been developed, with a gap in knowledge regarding the outcomes of these heterogeneous models. This report describes a satellite care model for remote full-care hemodialysis units managed homogenously in the province of Manitoba, Canada, without onsite nephrologists. Survival in remotely located full-care units is compared with a large, urban full-care center with onsite nephrologists. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Data from a Canadian provincial dialysis registry were extracted on 2663 patients between 1990 and 2005. All-cause mortality after initiation of chronic hemodialysis was assessed with Cox proportional hazards regression. Both short-term (1 year) and long-term (2 to 5 years) survival were analyzed. RESULTS: Survival for patients receiving remotely delivered care was shown to be better than for those receiving care in the urban care center with this particular Canadian model of care. Furthermore, there was no difference when assessing short- and long-term survival. This was independent of distance from the urban center. CONCLUSIONS: Chronic hemodialysis patients receiving remotely delivered care in a specialized facility attain comparable, if not better survival outcomes than their urban counterparts with direct onsite nephrology care. This model can potentially be adapted to other underserviced areas, including increasingly larger urban centers.