Self-reported MeasUrement of Physical and PsychosOcial Symptoms Response Tool (SUPPORT-dialysis): systematic symptom assessment and management in patients on in-centre haemodialysis - a parallel arm, non-randomised feasibility pilot study protocol.

INTRODUCTION: Patients with kidney failure experience symptoms that are often under-recognised and undermanaged. These symptoms negatively impact health-related quality of life and are associated with adverse clinical outcomes. Regular symptom assessment, using electronic patient reported outcomes measure (ePROMs) linked to systematic symptom management, could improve such outcomes. Clinical implementation of ePROMs have been successful in routine oncology care, but not used for patients on dialysis. In this study, we describe a pilot study of ePROM-based systematic symptom monitoring and management intervention in patients treated with in-centre haemodialysis. METHODS AND ANALYSIS: This is a parallel-arm, controlled pilot of adult patients receiving in-centre maintenance haemodialysis. Participants in the intervention arm will complete ePROMs once a month for 6 months. ePROMs will be scored real time and the results will be shared with participants and with the clinical team. Moderate-severe symptoms will be flagged using established cut-off scores. Referral options for those symptoms will be shared with the clinical team, and additional symptom management resources will also be provided for both participants and clinicians. Participants in the control arm will be recruited at a different dialysis unit, to prevent contamination. They will receive usual care, except that they will complete ePROMs without the presentation of results to participants of the clinical team. The primary objectives of the pilot are to assess (1) the feasibility of a larger, randomised clinical effectiveness trial and (2) the acceptability of the intervention. Interviews conducted with participants and staff will be assessed using a content analysis approach. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the University Health Network (REB#21-5199) and the William Osler Health System (#23-0005). All study procedures will be conducted in accordance with the standards of University Health Network research ethics board and with the 1964 Helsinki declaration and its later amendments. Results of this study will be shared with participants, patients on dialysis and other stakeholders using lay language summaries, oral presentations to patients and nephrology professionals. We will also be publishing the results in a peer-reviewed journal and at scientific meetings. PROTOCOL VERSION: 4 (16 November 2022). TRIAL REGISTRATION NUMBER: NCT05515991.

An Adjustable Dalteparin Sodium Dose Regimen for the Prevention of Clotting in the Extracorporeal Circuit in Hemodialysis: A Clinical Trial of Safety and Efficacy (the PARROT Study).

BACKGROUND: Dalteparin sodium, a low-molecular-weight heparin, is indicated for prevention of clotting in the extracorporeal circuit during hemodialysis (HD). Product labeling recommends a fixed single-bolus dose of 5000 international units (IU) for HD sessions lasting up to 4 hours, but adjustable dosing may be beneficial in clinical practice. OBJECTIVE: The aim of the PARROT study was to investigate the safety and efficacy of an adjustable dose of dalteparin in patients with end-stage renal disease requiring 3 to 4 HD sessions per week. DESIGN: A 7-week, open-label, multicenter study with a single treatment arm, conducted between October 2013 and March 2016. SETTING: Ten sites in Canada. PATIENTS: A total of 152 patients with end-stage renal disease requiring 3 to 4 HD sessions per week. MEASUREMENTS: The primary outcome was the proportion of HD sessions completed without premature termination due to inadequate anticoagulation. METHODS: All participants initially received a dose of 5000 IU dalteparin, which could be adjusted at subsequent HD sessions when clinically indicated, by increment or decrement of 500 or 1000 IU, with no specified dose limits. RESULTS: Patients were followed for 256 patient-months. Nearly all (99.9%; 95% confidence interval [CI]: 99.7-100) evaluable HD sessions were completed without premature clotting. Dose was adjusted for more than half (52.3%) of participants, mostly owing to clotting or access compression time >10 minutes. Median dalteparin dose was 5000 IU (range: 500-13 000 IU). There were no major bleeds, and minor bleeding was reported in 2.3% of all HD sessions. There was no evidence of bioaccumulation. LIMITATIONS: This short-term study, with a single treatment arm, was designed to optimize dalteparin dose using a flexible dosing schedule; it was not designed to specifically evaluate dalteparin dose minimization, provide a direct comparison of dalteparin versus unfractionated heparin, or provide information on long-term safety for flexible dalteparin dosing. Patients were excluded if they were at high risk of bleeding, including those on anticoagulants and those on antiplatelet agents other than aspirin <100 mg/d. CONCLUSIONS: Overall, an adjustable dalteparin sodium dose regimen allowed safe completion of HD, with clinical benefits over fixed dosing. TRIAL REGISTRATION: ClinicalTrials.gov NCT01879618, registered June 13, 2013.

CONTEXTE: La daltéparine sodique, une héparine de faible poids moléculaire, est indiquée pour prévenir la formation de caillots dans le circuit extracorporel durant l'hémodialyse (HD). Pour une séance de dialyse d'une durée maximale de quatre heures, l'étiquette du produit recommande une dose fixe de 5 000 unités internationales (U.I.) administrée en bolus. Cependant, il est possible qu'il puisse être bénéfique d'ajuster la dose en pratique. OBJECTIF: Le but de l'étude PARROT était d'analyser l'innocuité et l'efficacité d'une dose ajustable de daltéparine chez des patients atteints d'insuffisance rénale terminale (IRT) et nécessitant trois à quatre séances d'HD par semaine. TYPE D'ÉTUDE: Il s'agit d'une étude ouverte et multicentrique à traitement unique d'une durée de sept semaines couvrant la période entre octobre 2013 et mars 2016. CADRE: L'étude a eu lieu dans dix centres de dialyse au Canada. SUJETS: L'étude a inclus 152 patients atteints d'IRT et nécessitant trois à quatre séances d'HD par semaine. MESURES: Le résultat principal était la proportion de séances d'HD complétées, non interrompues de manière prématurée en raison d'une anticoagulation inadéquate. MÉTHODOLOGIE: Tous les participants ont initialement reçu 5000 U.I. de daltéparine, dose qui a pu être ajustée lors des séances subséquentes, lorsqu'indiqué par le contexte clinique, à raison d'augmentation ou de réduction de 500 ou 1 000 U.I., sans spécification quant aux doses limites. RÉSULTATS: Les patients ont été suivis sur une période de 256 mois-patients. Pratiquement toutes les séances d'HD évaluables (99,9 %; IC 95 % : 99,7-100) ont été complétées sans coagulation prématurée. La dose de daltéparine a été ajustée pour plus de la moitié (52,3 %) des participants, essentiellement en raison de coagulation ou d'un besoin de procéder à une compression de l'accès vasculaire au-delà de 10 minutes. La dose médiane de daltéparine était de 5 000 U.I. (entre 500 et 13 000 U.I.). Aucune hémorragie majeure n'a été rapportée, mais une hémorragie mineure est survenue dans 2,3 % de toutes les séances d'HD analysées. Aucune bioaccumulation n'a été détectée. LIMITES: Cette étude de courte durée à traitement unique a été conçue pour optimiser le dosage de daltéparine à l'aide d'un schéma de posologie flexible. Elle ne visait pas à évaluer spécifiquement la minimisation de la dose ou à fournir des informations sur l'innocuité à long terme d'une posologie flexible pour la daltéparine. Également, les patients à haut risque d'hémorragie ont été exclus de l'étude, notamment ceux qui prenaient des anticoagulants ou des antiplaquettaires autres qu'une dose quotidienne de moins de 100 mg d'aspirine. CONCLUSION: Dans l'ensemble, un schéma posologique flexible pour la daltéparine sodique a permis de compléter les séances d'HD de façon sécuritaire, en plus de fournir des avantages cliniques par rapport à une dose fixe.

Randomized pilot study to compare metal needles versus plastic cannulae in the development of complications in hemodialysis access.

BACKGROUND: Hemodialysis requires needle insertions every treatment. Needle injury (mechanical or hemodynamic) may cause complications (aneurysms/stenosis) that compromise dialysis delivery requiring interventions. Metal needles have a sharp slanted "V"-shaped cutting tip; plastic cannulae have a dull round tip and four side holes. Preliminary observations demonstrated a difference in intradialytic blood flow images and mean Doppler velocities at cannulation sites between the two devices. Complications from mechanical and hemodynamic trauma requiring interventions were compared in each group. MATERIALS AND METHODS: In all, 33 patients (13 females and 17 new accesses) were randomized to metal group (n = 17) and plastic group (n = 16). Mechanical trauma was minimized by having five nurses performing ultrasound-guided cannulations. Complications were identified by the clinician and addressed by the interventionalists, both blinded to study participation. Patients were followed for up to 12 months. RESULTS: Baseline characteristics were not significant. Procedures to treat complications along cannulation segments increased from 0.41 to 1.29 per patient (metal group) and decreased from 1.25 to 0.69 per patient (plastic group; p = 0.004). The relative risks of having an intervention (relative risk = 1.5, 95% confidence interval = 0.88-2.67) and having an infiltration during hemodialysis (relative risk = 2.26, 95% confidence interval = 1.03-4.97) were higher for metal needles. Time to first intervention trended in favor of plastic cannula (p = 0.069). Cost of supplies for these interventions was approximately CAD$20,000 lower for the plastic group. CONCLUSION: Decreased burden of illness related to cannulation (less infiltrations during hemodialysis) and Qb were associated with plastic cannulae. Decreased procedure costs were suggested during the study period in the plastic group.

Impact of needles in vascular access for hemodialysis.

This article reviews pragmatic aspects of cannulation practice and types of cannulation devices, as well as their impact in vascular access for hemodialysis. Hemodialysis treatment requires successful insertion of two needles for each dialysis treatment. The first needle is the arterial needle; it removes blood with toxin accumulation from the patient and delivers it to the dialysis machine. The second needle, called the venous needle, returns the purified blood from the dialyzer to the patient. Mechanical and hemodynamic trauma related to needle insertions will be discussed.

Are you SURE about your vascular access? Exploring factors influencing vascular access decisions with chronic hemodialysis patients and their nurses.

A major decision for patients with stage 5 chronic kidney disease (CKD) relates to vascular access (VA) for treatment. Patients who receive pre-dialysis care often defer making a decision, which results in initiation of hemodialysis (HD) with a central venous catheter (CVC) in an urgent or emergent situation. Little is known about how individuals make decisions around VA. In this context, a mixed-methods study was undertaken to explore uncertainty related to changing their VA from an existing CVC to a graft or fistula. Quantitative assessment was measured using the SURE tool and interviews with patients and nurses were conducted. Results revealed that none of the 16 patient participants reported uncertainty. Qualitative findings revealed that patient decisions about access were impacted by observations, experiences, and dialogue in the hemodialysis unit. Study findings have important implications including the challenge of reconciling epidemiologic population-based risk measurement to the individual patient's situation. Moreover, the SURE tool was viewed as a mechanism to open a dialogue to confirm patients' decisions and provide further education and/or support following HD initiation.

Development of competencies for the use of bedside ultrasound for assessment and cannulation of hemodialysis vascular access.

Use of ultrasound for hemodialysis vascular access assessment and real-time cannulation requires specialized training. In order to obtain basic hand-eye coordination, theoretical sessions on ultrasound use, as well as practical sessions using phantom models are recommended prior to its use in the clinical setting with patients. New users of this technology need to consider that all competencies can be achieved with daily use of ultrasound at the bedside. It takes approximately 500 guided cannulations to achieve the highest level of competency described above.

Supercath Safety Clampcath buttonhole creation: complication of catheter breakage.

The creation of buttonhole tracks with Supercath Safety Clampcath is a novel and simple technique that allows dull fistula needle insertions with relative ease and diminished pain. As greater experience with this procedure develops, new issues arise for consideration. We report an unexpected complication of Supercath Safety Clampcath catheter breakage that may be due to physical distortions as a result of its location in the antecubital fossa just proximal to the elbow joint. We present a review of our experience and a framework for the safe ongoing use of this device for creation of buttonholes in fistula for hemodialysis.

When is a new fistula mature? The emerging science of fistula cannulation.

Once an arteriovenous fistula is established, the blood vessels are subjected to marked changes in hemodynamic forces that trigger remodeling to re-establish baseline parameters of sheer and hoop stress. These homeostatic processes culminate in two requirements that define an adequate and enduring access. First, blood flow must increase to provide amounts that will provide adequate delivery of blood to the artificial kidney. Second, the vessel wall must undergo changes that will allow it to withstand repeated cannulation. Hence, a fistula is mature when it can do what it sets out to do (flow readiness) despite what is being done to it (cannulation readiness). Although flow has been measured with Doppler, high-frequency ultrasound is needed to measure vessel wall thickness to determine hoop stress. Beyond the wall of the vessel, the concept of cannulation readiness depends on the skill and expertise of the cannulator.

Effect of fish oil supplementation on graft patency and cardiovascular events among patients with new synthetic arteriovenous hemodialysis grafts: a randomized controlled trial.

CONTEXT: Synthetic arteriovenous grafts, an important option for hemodialysis vascular access, are prone to recurrent stenosis and thrombosis. Supplementation with fish oils has theoretical appeal for preventing these outcomes. OBJECTIVE: To determine the effect of fish oil on synthetic hemodialysis graft patency and cardiovascular events. DESIGN, SETTING, AND PARTICIPANTS: The Fish Oil Inhibition of Stenosis in Hemodialysis Grafts (FISH) study, a randomized, double-blind, controlled clinical trial conducted at 15 North American dialysis centers from November 2003 through December 2010 and enrolling 201 adults with stage 5 chronic kidney disease (50% women, 63% white, 53% with diabetes), with follow-up for 12 months after graft creation. INTERVENTIONS: Participants were randomly allocated to receive fish oil capsules (four 1-g capsules/d) or matching placebo on day 7 after graft creation. MAIN OUTCOME MEASURE: Proportion of participants experiencing graft thrombosis or radiological or surgical intervention during 12 months' follow-up. RESULTS: The risk of the primary outcome did not differ between fish oil and placebo recipients (48/99 [48%] vs 60/97 [62%], respectively; relative risk, 0.78 [95% CI, 0.60 to 1.03; P = .06]). However, the rate of graft failure was lower in the fish oil group (3.43 vs 5.95 per 1000 access-days; incidence rate ratio [IRR], 0.58 [95% CI, 0.44 to 0.75; P < .001]). In the fish oil group, there were half as many thromboses (1.71 vs 3.41 per 1000 access-days; IRR, 0.50 [95% CI, 0.35 to 0.72; P < .001]); fewer corrective interventions (2.89 vs 4.92 per 1000 access-days; IRR, 0.59 [95% CI, 0.44 to 0.78; P < .001]); improved cardiovascular event-free survival (hazard ratio, 0.43 [95% CI, 0.19 to 0.96; P = .04]); and lower mean systolic blood pressure (-3.61 vs 4.49 mm Hg; difference, -8.10 [95% CI, -15.4 to -0.85]; P = .01). CONCLUSIONS: Among patients with new hemodialysis grafts, daily fish oil ingestion did not decrease the proportion of grafts with loss of native patency within 12 months. Although fish oil improved some relevant secondary outcomes such as graft patency, rates of thrombosis, and interventions, other potential benefits on cardiovascular events require confirmation in future studies. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN15838383.

Arteriovenous fistulas for hemodialysis: application of high-frequency US to assess vein wall morphology for cannulation readiness.

PURPOSE: To determine whether venous wall thickness and hoop (circumferential) stress, as determined with high-frequency ultrasonography (US), can predict cannulation readiness in arteriovenous fistulas (AVFs). MATERIALS AND METHODS: Institutional review board approval and informed consent were obtained for this prospective study. To determine the US appearance of the venous wall, an AVF specimen was excised and scanned in a bath of degassed lactated Ringer solution with a 55-MHz probe. The appearance of the wall at high-frequency US was correlated with histologic findings. High-frequency (40-55-MHz) US was used to image the near-field AVF venous wall of 14 men (mean age, 59 years ± 11 [standard deviation]) and six women (mean age, 55 years ± 14) with newly created AVFs within 1 week of cannulation between January 2008 and December 2009. Measurements of the intima-media thickness (IMT) were generated by three independent observers who were blinded to outcomes. Intraclass correlation analysis was performed. Cannulation readiness was defined as no extravasation during the first dialysis treatment. RESULTS: By using high-frequency US, the IMT was defined as the sum of a thin echogenic blood-intima interface and a uniform hypoechoic media. The mean IMT of the no extravasation group (0.16 mm ± 0.03) was greater than that of the extravasation group (0.10 mm ± 0.02) (P < .001). A minimum threshold IMT of 0.13 mm (P < .001) was associated with successful cannulation. The mean hoop stress of the no extravasation group (246 kPa ± 57) was lower than that of the extravasation group (530 kPa ± 199) (P < .001). A maximum hoop stress threshold of 248 kPa was associated with successful cannulation (P = .009). CONCLUSION: Venous IMT and hoop stress assessed with high-frequency US can predict cannulation readiness in AVFs that are clinically deemed mature.

Exploring the impact of a decision support intervention on vascular access decisions in chronic hemodialysis patients: study protocol.

BACKGROUND: In patients with Stage 5 Chronic Kidney Disease who require renal replacement therapy a major decision concerns modality choice. However, many patients defer the decision about modality choice or they have an urgent or emergent need of RRT, which results in them starting hemodialysis with a Central Venous Catheter. Thereafter, efforts to help patients make more timely decisions about access choices utilizing education and resource allocation strategies met with limited success resulting in a high prevalent CVC use in Canada. Providing decision support tailored to meet patients' decision making needs may improve this situation. The Registered Nurses Association of Ontario has developed a clinical practice guideline to guide decision support for adults living with Chronic Kidney Disease (Decision Support for Adults with Chronic Kidney Disease.) The purpose of this study is to determine the impact of implementing selected recommendations this guideline on priority provincial targets for hemodialysis access in patients with Stage 5 CKD who currently use Central Venous Catheters for vascular access. METHODS/DESIGN: A non-experimental intervention study with repeated measures will be conducted at St. Michaels Hospital in Toronto, Canada. Decisional conflict about dialysis access choice will be measured using the validated SURE tool, an instrument used to identify decisional conflict. Thereafter a tailored decision support intervention will be implemented. Decisional conflict will be re-measured and compared with baseline scores. Patients and staff will be interviewed to gain an understanding of how useful this intervention was for them and whether it would be feasible to implement more widely. Quantitative data will be analyzed using descriptive and inferential statistics. Statistical significance of difference between means over time for aggregated SURE scores (pre/post) will be assessed using a paired t-test. Qualitative analysis with content coding and identification of themes will be conducted for the focus group and patient interview data. DISCUSSION: Coupling the SURE tool with a decision support system structured so that a positive test result triggers providers to help patients through the decision-making process and/or refer patients to appropriate resources could benefit patients and ensure they have the opportunity to make informed HD access choices.

Use of the BioHole™ device for the creation of tunnel tracks for buttonhole cannulation of fistula for hemodialysis.

Buttonhole cannulation is a method of cannulation of native arteriovenous fistulae traditionally practiced by self-cannulators. At St Michael's Hospital, this method has been modified to allow its use in problematic fistulae by multiple cannulators. In a busy dialysis unit, the need for a few specific cannulators to establish the tunnel tracks in combination with the variable dialysis schedules creates logistical challenges. A new method of creating tunnel tracks with the use of the BioHole™ device was evaluated. Buttonhole tracks were created in 12 patients using a peg of polycarbonated material with a holder (BioHole™ kit). The peg was inserted into the path left by the hemodialysis sharp needle following the index cannulation. Four of the 12 patients had an alternate access. Buttonhole tracks were successfully created in all the patients, albeit in 2 patients, the initial attempt to establish buttonhole tracks was aborted due to complications and the procedure was rescheduled. Compared with the modified buttonhole technique, pain on cannulation following track creation was significantly less in the BioHole™ group (P < 0.001). Ease of cannulation was significantly improved in the BioHole™ group (P<0.05) when compared with that in thrice-weekly patients using the modified buttonhole technique. Hemostasis postdialysis did not differ between the study groups. The use of the BioHole™ device is effective in the creation of tunnel tracks for buttonhole cannulation, is associated with less pain, and simplifies the logistics of arranging patient and nurses' schedules.

Relationship of blood pressure to retinal vessel diameter in type 1 diabetes mellitus.

OBJECTIVE: To examine the relationship of blood pressure (BP) and use of angiotensin-receptor blocker or angiotensin-converting enzyme inhibitor to retinal vessel diameter in normotensive, normoalbuminuric persons with type 1 diabetes mellitus. METHODS: In a randomized, controlled clinical trial, clinic and 24-hour ambulatory BPs were measured in persons with type 1 diabetes mellitus and gradable fundus photographs both at baseline (n = 147) and at 5-year follow-up (n = 124). Retinal arteriole and venule diameters were measured by a computer-assisted technique. Individual arteriole and venule measurements were combined into summary indexes that reflect the average retinal arteriole (central retinal arteriole equivalent [CRAE]) and venule (central retinal venule equivalent [CRVE]) diameter of an eye, respectively. RESULTS: While controlling for age, study site, glycosylated hemoglobin level, and ambulatory pulse rate, the daytime ambulatory systolic (-0.29-microm effect per 1 mm Hg; P = .02), daytime ambulatory diastolic (-0.44-microm effect per 1 mm Hg; P = .04), nighttime ambulatory systolic (-0.27-microm effect per 1 mm Hg; P = .03), and 24-hour ambulatory systolic (-0.31-microm effect per 1 mm Hg; P = .03) BPs were cross-sectionally associated with a smaller CRAE. While controlling for age, study site, glycosylated hemoglobin level, ambulatory pulse rate, and baseline CRAE, no BP measure was associated with a change in CRAE or CRVE during 5 years of follow-up. Treatment with losartan potassium or enalapril maleate was not associated with a statistically significant change in CRAE or CRVE. CONCLUSION: Angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker therapy does not affect retinal arteriole or venule diameter in normotensive persons with type 1 diabetes mellitus. Trial Registration clinicaltrials.gov Identifier: NCT00143949.

Glutathione and riboflavin status in supplemented patients undergoing home nocturnal hemodialysis versus standard hemodialysis.

BACKGROUND: Patients on conventional hemodialysis (HD) have elevated markers of oxidative stress and chronic inflammation, which may contribute to a high prevalence of cardiovascular disease. Glutathione (GSH), an important intracellular antioxidant, requires cysteine as a rate-limiting amino acid for its synthesis and riboflavin for its regeneration. OBJECTIVES: We aimed to examine whether erythrocyte GSH (eGSH) concentrations and riboflavin status are influenced by the increased dialysis dose provided to vitamin-supplemented patients receiving home nocturnal hemodialysis (HNHD) (6-8 hours/session, 5-7 nights/week) compared with patients on standard hemodialysis (SHD) (4 hours/session, 3 days/week). METHOD: This was a cross-sectional comparative study involving 30 patients undergoing SHD or HNHD regimens and a group of 15 healthy control subjects (HC). We measured eGSH concentration by liquid chromatography-tandem mass spectrometry, riboflavin status by eGSH reductase activity coefficient (EGRAC) as well as plasma total cysteine (Cys) and total homocysteine (Hcy), vitamin C by high-performance liquid chromatography, and C-reactive protein (CRP) by standard method. Estimated dietary protein and energy intakes were determined by 3-day food records, and nutritional status was assessed by subjective global assessment (SGA). RESULTS: There were no significant differences among groups in eGSH concentration, EGRAC, dietary protein intake, and SGA score. SHD patients had significantly higher plasma Cys (P < .001) and Hcy compared with HNHD and HC groups (P = .048). Vitamin C was significantly lower (P = .01) and CRP significantly higher (P = .048) in both HD groups compared with HC. CONCLUSION: eGSH concentration appears to be unaffected by dialysis dose in well-nourished HD patients.

Renal and retinal effects of enalapril and losartan in type 1 diabetes.

BACKGROUND: Nephropathy and retinopathy remain important complications of type 1 diabetes. It is unclear whether their progression is slowed by early administration of drugs that block the renin-angiotensin system. METHODS: We conducted a multicenter, controlled trial involving 285 normotensive patients with type 1 diabetes and normoalbuminuria and who were randomly assigned to receive losartan (100 mg daily), enalapril (20 mg daily), or placebo and followed for 5 years. The primary end point was a change in the fraction of glomerular volume occupied by mesangium in kidney-biopsy specimens. The retinopathy end point was a progression on a retinopathy severity scale of two steps or more. Intention-to-treat analysis was performed with the use of linear regression and logistic-regression models. RESULTS: A total of 90% and 82% of patients had complete renal-biopsy and retinopathy data, respectively. Change in mesangial fractional volume per glomerulus over the 5-year period did not differ significantly between the placebo group (0.016 units) and the enalapril group (0.005, P=0.38) or the losartan group (0.026, P=0.26), nor were there significant treatment benefits for other biopsy-assessed renal structural variables. The 5-year cumulative incidence of microalbuminuria was 6% in the placebo group; the incidence was higher with losartan (17%, P=0.01 by the log-rank test) but not with enalapril (4%, P=0.96 by the log-rank test). As compared with placebo, the odds of retinopathy progression by two steps or more was reduced by 65% with enalapril (odds ratio, 0.35; 95% confidence interval [CI], 0.14 to 0.85) and by 70% with losartan (odds ratio, 0.30; 95% CI, 0.12 to 0.73), independently of changes in blood pressure. There were three biopsy-related serious adverse events that completely resolved. Chronic cough occurred in 12 patients receiving enalapril, 6 receiving losartan, and 4 receiving placebo. CONCLUSIONS: Early blockade of the renin-angiotensin system in patients with type 1 diabetes did not slow nephropathy progression but slowed the progression of retinopathy. (ClinicalTrials.gov number, NCT00143949.)

A simple method to create buttonhole cannulation tracks in a busy hemodialysis unit.

The preference for fistulae as the hemodialysis access of choice has led to a significant number of accesses that are less than ideal for cannulation. Buttonhole cannulation is ideal for such accesses, but the technique for creation provides major challenges. In 12 patients, buttonhole tunnel tracks were created by leaving the polyurethane catheter of a Clampcath hemodialysis needle indwelling for 10 days after the initial cannulation. After each dialysis the catheter was flushed, and dressed with an antibacterial ointment and gauze. Dialysis was carried out via the catheter during that time. After day 10, the catheter was removed, the tunnel track covered with an antibacterial dressing and the tunnel track was cannulated with a dull buttonhole needle at the next dialysis. Successful buttonhole accesses were created in 11 patients after 10 days, the 12th patient required a single sharp needle cannulation before using dull needles. During the first 2 weeks of dull needle cannulation both pain experienced on cannulation and the difficulty cannulating the access were significantly less than in the classical buttonhole technique (P<0.01). Complications during the follow-up period (6 months-1.5 years) included difficulty cannulating with a dull needle (22) and antibacterial agent induced contact dermatitis (4). There was no episode of sepsis or tunnel track infection. Initial cannulation of the fistula using a Clampcath hemodialysis needle, leaving the polyurethane catheter indwelling for 10 days, is a simple, safe, and effective technique for the creation of buttonhole tunnel tracks.

In-center nocturnal hemodialysis: another option in the management of chronic kidney disease.

BACKGROUND AND OBJECTIVES: Some patients are not optimally treated by conventional in-center hemodialysis (HD) and are unable to perform home HD. We examined the effect of in-center thrice-weekly nocturnal HD (INHD) on patient outcomes. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Patients who were not optimally treated on conventional HD were offered INHD. Thirty-nine patients' laboratory data and medication use were analyzed for the 12 mo before and after conversion to INHD until September 1, 2007. Quality of life on conventional HD and INHD was compared. RESULTS: After conversion to INHD, median values for phosphorus decreased from 5.9 to 3.7 mg/dl (P < 0.01), alkaline phosphatase level increased from 84 to 161 U/L (P < 0.01), and percentage reduction in urea increased from 74 to 89% (P < 0.01). The mean number of antihypertensive drugs prescribed declined from 2.0 to 1.5 (P < 0.05) during the course of INHD, and the mean daily dosage of phosphate binders declined from 6.2 to 4.9 at study end (P < 0.05). There was a significant reduction in erythropoietin-stimulating agent use of 1992 U/wk (P < 0.01). There was no significant change in median hemoglobin, iron saturation, corrected calcium, or parathyroid hormone levels. Overall, quality of life, sleep, intradialytic cramps, appetite, and energy level all improved significantly on INHD. CONCLUSIONS: INHD offers an effective form of HD for long-term dialysis patients who are unable to perform home HD.

Molecular comparison of Mycobacterium avium isolates from clinical and environmental sources.

We collected Mycobacterium avium isolates from clinical and drinking-water sources and compared isolates among themselves and to each other using molecular methods. Four clinical isolates were related to water isolates. Groups of indistinguishable clinical isolates were identified. The groups of identical clinical isolates suggest a common source of exposure.