COVID-19 pandemic: a qualitative study with an opportunity-centric approach from an ICU perspective in a teaching hospital. Upsides worth to secure?

OBJECTIVES: During the COVID-19 pandemic, the staff in the intensive care unit (ICU) was materially, physically and emotionally challenged. This qualitative study investigated the effects that ICU staff experienced and were considered of value to be permanently implemented. SETTING: ICU in an university medical centre during the first wave of the COVID-19 pandemic. DESIGN: An opportunity-centric approach was applied in individual semi-structured interviews to optimise the achieved results and was guided by the theoretical model of appreciative inquiry (AI). PARTICIPANTS: Fifteen ICU staff members (8 nurses and 7 intensivists) participated. RESULTS: Working during the COVID-19 pandemic catalysed interprofessional collaboration and team learning in the ICU on an individual and team level, centred around a common goal: taking care of critically ill patients with COVID-19. The effect of interprofessional collaboration was that provisions were taken care of quicker than usual, without bureaucratic delays. However, this effect was experienced to be transient. Also, ICU staff perceived limited possibilities to help patients and families around the palliative phase, and they perceived a lack of appreciation from higher management. This is a point of future attention: how to make this perceived lack of appreciation more visible to all (ICU) staff. CONCLUSION: Regarding our primary question, the ICU staff voiced that the direct communication and collaboration are the most important elements of the COVID-19 peak they would like to preserve. Furthermore, it was learnt that consolation and support for family members should not be forgotten. Considering the results, we believe that further research concerning team reflexivity might contribute to (or enhance) our knowledge about working together during and after a crisis.

Efficacy of postmortem CT and tissue sampling in establishing the cause of death in clinical practice: a prospective observational study.

AIMS: The aim of this study is to evaluate whether agreement with autopsy-determined cause of death (COD) increases by use of postmortem CT (PMCT) or PMCT in combination with postmortem sampling (PMS), when compared with clinical assessment only. METHODS: This prospective observational study included deceased patients from the intensive care unit and internal medicine wards between October 2013 and August 2017. The primary outcome was percentage agreement on COD between the reference standard (autopsy) and the alternative postmortem examinations (clinical assessment vs PMCT or PMCT+PMS). In addition, the COD of patient groups with and without conventional autopsy were compared with respect to involved organ systems and pathologies. RESULTS: Of 730 eligible cases, 144 could be included for analysis: 63 underwent PCMT without autopsy and 81 underwent both PMCT and autopsy. Agreement with autopsy-determined COD was significantly higher for both PMCT with PMS (42/57, 74%), and PMCT alone (53/81, 65%) than for clinical assessment (40/81, 51%; p=0.007 and p=0.03, respectively). The difference in agreement between PMCT with PMS and PMCT alone was not significant (p=0.13). The group with autopsy had a significantly higher prevalence of circulatory system involvement and perfusion disorders, and a lower prevalence of pulmonary system involvement. CONCLUSION: PMCT and PMS confer additional diagnostic value in establishing the COD. Shortcomings in detecting vascular occlusions and perfusion disorders and susceptibility to pulmonary postmortem changes could in future be improved by additional techniques. Both PMCT and PMS are feasible in clinical practice and an alternative when autopsy cannot be performed.

High vitamin K status is prospectively associated with decreased left ventricular mass in women: the Hoorn Study.

BACKGROUND: Vitamin K is associated with reduced cardiovascular disease risk such as heart failure, possibly by carboxylation of matrix-gla protein (MGP), a potent inhibitor of vascular calcification. The relationship of vitamin K intake or status with cardiac structure and function is largely unknown. Therefore this study aims to investigate the prospective association of vitamin K status and intake with echocardiographic measures. METHODS: This study included 427 participants from the Hoorn Study, a population-based cohort. Vitamin K status was assessed at baseline by plasma desphospho-uncarboxylated MGP (dp-ucMGP) with higher concentrations reflecting lower vitamin K status. Vitamin K intake was assessed at baseline with a validated food-frequency questionnaire. Echocardiography was performed at baseline and after a mean follow-up time of 7.6, SD=±0.7 years. We used linear regression for the association of vitamin K status and intake with left ventricular ejection fraction (LVEF), left atrial volume index (LAVI) and left ventricular mass index (LVMI), adjusted for potential confounders. RESULTS: The mean age was 66.8, SD=±6.1 years (51% were male). A high vitamin K status was prospectively associated with decreased LVMI (change from baseline to follow-up: -5.0, 95% CI: -10.5;0.4 g/m2.7) for the highest quartile compared to the lowest in women (P-interaction sex=0.07). No association was found in men. Vitamin K status was not associated with LVEF or LAVI. Vitamin K intake was not associated with any of the echocardiographic measures. CONCLUSIONS: This study showed a high vitamin K status being associated with decreased LVMI only in women, while intakes of vitamin K were not associated with any cardiac structure or function measures. These results extend previous findings for a role of vitamin K status to decrease heart failure risk.

Predicting mortality of individual patients with COVID-19: a multicentre Dutch cohort.

OBJECTIVE: Develop and validate models that predict mortality of patients diagnosed with COVID-19 admitted to the hospital. DESIGN: Retrospective cohort study. SETTING: A multicentre cohort across 10 Dutch hospitals including patients from 27 February to 8 June 2020. PARTICIPANTS: SARS-CoV-2 positive patients (age ≥18) admitted to the hospital. MAIN OUTCOME MEASURES: 21-day all-cause mortality evaluated by the area under the receiver operator curve (AUC), sensitivity, specificity, positive predictive value and negative predictive value. The predictive value of age was explored by comparison with age-based rules used in practice and by excluding age from the analysis. RESULTS: 2273 patients were included, of whom 516 had died or discharged to palliative care within 21 days after admission. Five feature sets, including premorbid, clinical presentation and laboratory and radiology values, were derived from 80 features. Additionally, an Analysis of Variance (ANOVA)-based data-driven feature selection selected the 10 features with the highest F values: age, number of home medications, urea nitrogen, lactate dehydrogenase, albumin, oxygen saturation (%), oxygen saturation is measured on room air, oxygen saturation is measured on oxygen therapy, blood gas pH and history of chronic cardiac disease. A linear logistic regression and non-linear tree-based gradient boosting algorithm fitted the data with an AUC of 0.81 (95% CI 0.77 to 0.85) and 0.82 (0.79 to 0.85), respectively, using the 10 selected features. Both models outperformed age-based decision rules used in practice (AUC of 0.69, 0.65 to 0.74 for age >70). Furthermore, performance remained stable when excluding age as predictor (AUC of 0.78, 0.75 to 0.81). CONCLUSION: Both models showed good performance and had better test characteristics than age-based decision rules, using 10 admission features readily available in Dutch hospitals. The models hold promise to aid decision-making during a hospital bed shortage.

Post-Contrast Acute Kidney Injury and Intravenous Prophylactic Hydration: An Update.

BACKGROUND: Despite tremendous improvement in molecular properties over the last century, intravascular injection of iodinated contrast material may still have systemic and hemodynamic consequences. Patients with pre-existing renal insufficiency may be at risk for acute kidney injury, which may be associated with an increased risk of the need for dialysis and mortality in the long term. Many questions as to the physiological pathways, optimal definition, and incidence of contrast-induced acute kidney injury remain open. These uncertainties are reflected in the changing landscape of this field in terms of nomenclature, research, and clinical practice. METHODS: Clinical practice guidelines for the prevention of post-contrast acute kidney injury all recommend giving prophylaxis in the form of intravenous hydration to high-risk patients. Solid evidence for this strategy is lacking. This article gives an overview of the changing landscape of post-contrast acute kidney injury and prophylactic intravenous hydration, with the aim of supporting informed decision-making in clinical practice. RESULTS: Recent data have caused a shift in guideline recommendations: 90 % of patients formerly considered high-risk for contrast-induced acute kidney injury no longer qualify for prophylaxis. The remaining high-risk patients, with severe chronic kidney disease, represent a vulnerable population for whom intravenous hydration may provide some benefits but also carries risk. CONCLUSION: Intravenous hydration may benefit 'new' high-risk patients. However, it also confers risk. A dual approach to screening patients will help avoid this risk in clinical practice. KEY POINTS: · Intravenous hydration is the cornerstone for preventing contrast-induced acute kidney injury. · Solid evidence is lacking; recent data caused a shift in guideline recommendations. · Intravenous hydration may benefit 'new' high-risk patients with severe chronic kidney disease; however, it also confers risk. · A dual approach to screening patients will help avoid this risk in clinical practice. CITATION FORMAT: · Nijssen E, Rennenberg R, Nelemans P et al. Post-Contrast Acute Kidney Injury and Intravenous Prophylactic Hydration: An Update. Fortschr Röntgenstr 2021; 193: 151 - 159.

A Systematic Review of Methods for Medical Record Analysis to Detect Adverse Events in Hospitalized Patients.

OBJECTIVE: In this systematic review, we evaluate 2 of the most used trigger tools according to the criteria of the World Health Organization for evaluating methods. METHODS: We searched Embase, PubMed, and Cochrane databases for studies (2000-2017). Studies were included if medical record review (MRR) was performed with either the Global Trigger Tool or the Harvard Medical Practice Study in a hospital population. Quality assessment was performed in duplicate. Fifty studies were included, and results were reported for every criterion separately. RESULTS: Medical record review reveals more adverse events (AEs) than any other method. However, at the same time, it detects different AEs. The costs of an AE were on average €4296. Considerable efforts have been made worldwide in health care to improve safety and to reduce errors. These have resulted in some positive effects. The literature showed that MRR is focused on several domains of quality of care and seems suitable for both small and large cohorts. Furthermore, we found a moderate to substantial agreement for the presence of a trigger and a moderate to good agreement for the presence of an AE. CONCLUSIONS: Medical record review with a trigger tool is a reasonably well-researched method for the evaluation of the medical records for AEs. However, looking at the World Health Organization criteria, much research is still lacking or of moderate quality. Especially for the cost of detecting AEs, valuable information is missing. Moreover, knowledge of how MRR changes quality and safety of care should be evaluated.

Introduction of postmortem CT increases the postmortem examination rate without negatively impacting the rate of traditional autopsy in daily practice: an implementation study.

AIM: The aim of this implementation study was to assess the effect of postmortem CT (PMCT) and postmortem sampling (PMS) on (traditional) autopsy and postmortem examination rates. Additionally, the feasibility of PMCT and PMS in daily practice was assessed. METHODS: For a period of 23 months, PMCT and PMS were used as additional modalities to the autopsy at the Department of Internal Medicine. The next of kin provided consent for 123 postmortem examinations. Autopsy rates were derived from the Dutch Pathology Registry, and postmortem examination rates were calculated for the period before, during and after the study period, and the exclusion rate, table time, time interval to informing the referring clinicians with results and the time interval to the Multidisciplinary Mortality Review Board (MMRB) meeting were objectified to assess the feasibility. RESULTS: The postmortem examination rate increased (from 18.8% to 32.5%, p<0.001) without a decline in the autopsy rate. The autopsy rate did not change substantially after implementation (0.2% decrease). The exclusion rate was 2%, the table time was 23 min, and a median time interval of 4.1 hours between PMCT and discussing its results with the referring clinicians was observed. Additionally, more than 80% of the MMRB meetings were held within 8 weeks after the death of the patient. CONCLUSIONS: Our study shows that the implementation of a multidisciplinary postmortem examination is feasible in daily practice and does not adversely affect the autopsy rate, while increasing the postmortem examination rate.

Clinical Relevance of Unexpected Findings of Post-Mortem Computed Tomography in Hospitalized Patients: An Observational Study.

Background and objective: The current literature describing the use of minimally invasive autopsy in clinical care is mainly focused on the cause of death. However, the identification of unexpected findings is equally important for the evaluation and improvement of daily clinical care. The purpose of this study was to analyze unexpected post-mortem computed tomography (PMCT) findings of hospitalized patients and assess their clinical relevance. Materials and methods: This observational study included patients admitted to the internal medicine ward. Consent for PMCT and autopsy was requested from the next of kin. Decedents were included when consent for at least PMCT was obtained. Consent for autopsy was not obtained for all decedents. All findings reported by PMCT were coded with an International Classification of Diseases (ICD) code. Unexpected findings were identified and subsequently categorized for their clinical relevance by the Goldman classification. Goldman class I and III were considered clinically relevant. Additionally, correlation with autopsy results and ante-mortem imaging was performed. Results: In total, 120 decedents were included and evaluated for unexpected findings on PMCT. Of them, 57 decedents also underwent an autopsy. A total of 1020 findings were identified; 111 correlated with the cause of death (10.9%), 508 were previously reported (49.8%), 99 were interpreted as post-mortem changes (9.7%), and 302 were classified as unexpected findings (29.6%). After correlation with autopsy (in 57 decedents), 24 clinically relevant unexpected findings remained. These findings were reported in 18 of 57 decedents (32%). Interestingly, 25% of all unexpected findings were not reported by autopsy. Conclusion: Many unexpected findings are reported by PMCT in hospitalized patients, a substantial portion of which is clinically relevant. Additionally, PMCT is able to identify pathology and injuries not reported by conventional autopsy. A combination of PMCT and autopsy can thus be considered a more comprehensive and complete post-mortem examination.

The prevalence of pulmonary embolism in patients with COVID-19 and respiratory decline: A three-setting comparison.

BACKGROUND: The risk of pulmonary embolism (PE) in patients with Coronavirus Disease 2019 (COVID-19) is recognized. The prevalence of PE in patients with respiratory deterioration at the Emergency Department (ED), the regular ward, and the Intensive Care Unit (ICU) are not well-established. OBJECTIVES: We aimed to investigate how often PE was present in individuals with COVID-19 and respiratory deterioration in different settings, and whether or not disease severity as measured by CT-severity score (CTSS) was related to the occurrence of PE. PATIENTS/METHODS: Between April 6th and May 3rd, we enrolled 60 consecutive adult patients with confirmed COVID-19 from the ED, regular ward and ICU who met the pre-specified criteria for respiratory deterioration. RESULTS: A total of 24 (24/60: 40% (95% CI: 28-54%)) patients were diagnosed with PE, of whom 6 were in the ED (6/23: 26% (95% CI: 10-46%)), 8 in the regular ward (8/24: 33% (95% CI: 16-55%)), and 10 in the ICU (10/13: 77% (95% CI: 46-95%)). CTSS (per unit) was not associated with the occurrence of PE (age and sex-adjusted OR 1.06 (95%CI 0.98-1.15)). CONCLUSION: The number of PE diagnosis among patients with COVID-19 and respiratory deterioration was high; 26% in the ED, 33% in the regular ward and 77% in the ICU respectively. In our cohort CTSS was not associated with the occurrence of PE. Based on the high number of patients diagnosed with PE among those scanned we recommend a low threshold for performing computed tomography angiography in patients with COVID-19 and respiratory deterioration.

Limited external reproducibility restricts the use of medical record review for benchmarking.

Background: Medical record review (MRR) is used to assess the quality and safety in hospitals. It is increasingly used to compare institutions. Therefore, the external reproducibility should be high. In the current study, we evaluated this external reproducibility for the assessment of an adverse event (AE) in a sample of records from two university medical centres in the Netherlands, using the same review method. Methods: From both hospitals, 40 medical records were randomly chosen from patient files of deceased patients that had been evaluated in the preceding years by the internal review committees. After reviewing by the external committees, we assessed the overall and kappa agreement by comparing the results of both review rounds (once by the own internal committee and once by the external committee). This was calculated for the presence of an AE, preventability and contribution to death. Results: Kappa for the presence of AEs was moderate (k=0.47). For preventability, the agreement was fair (k=0.39) and poor for contribution to death (k=-0.109). Conclusion: We still believe that MRR is suitable for the detection of general issues concerning patient safety. However, based on the outcomes of this study, we would advise to be careful when using MRR for benchmarking.

Prophylaxis in High-Risk Patients With eGFR < 30 mL/min/1.73 m2: Get the Balance Right.

OBJECTIVES: Clinical guidelines recommend prophylactic intravenous fluids for patients with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m to prevent adverse postcontrast outcomes. These patients represent a small minority of the population receiving intravascular iodinated contrast material, and data are not readily available. The current study aim is to gain insight into positive and negative effects of prophylaxis by comparing postcontrast outcomes in high-risk patients who did and did not receive prophylaxis. MATERIALS AND METHODS: Observational data were gathered over 4 years. Inclusion criteria were age 18 years or older, eGFR less than 30 mL/min/1.73 m, and elective intravascular iodinated contrast administration. Exclusion criteria were dialysis and nonstandard periprocedural prophylaxis. Primary outcome was postcontrast acute kidney injury (>25% or >44 µmol/L serum creatinine increase within 2-5 days). Secondary outcomes were change in eGFR, 5 mL/min/1.73 m or greater eGFR decline, dialysis, and mortality at 1 month postcontrast including primary cause, as well as complications of prophylaxis. Results were stratified by contrast procedure type and corrected for potential confounders. RESULTS: Of all 55,474 elective procedures with intravascular contrast administration, 362 patients met the inclusion criteria: 281 (78%) received standard 0.9% NaCl prophylaxis and 81 (22%) received no prophylaxis. Prophylaxis versus no prophylaxis adjusted odds ratios were nonsignificant and less than 1 for postcontrast renal outcomes (postcontrast acute kidney injury, eGFR decline, dialysis), indicating a trend toward a protective effect of prophylaxis. For mortality, adjusted odds ratios were nonsignificant and greater than 1, indicating a trend toward higher mortality risk after prophylaxis. Of the primary causes of death analyzed in prophylaxis patients, 24% (5/21) were related to prophylaxis. Among 281 prophylaxis patients, 18 (6.4%) complications of prophylaxis occurred: 15 heart failures and 3 arrhythmias. CONCLUSIONS: Based on this study, no standard recommendation with regard to giving or withholding prophylaxis can be given. Prophylactic fluids may confer some protection against postcontrast renal adverse events but may also contribute toward increased risk of short-term death. In this setting, benefits and risks of prophylaxis must be carefully weighed and cardiac parameters assessed for each individual patient.

The Harvard medical practice study trigger system performance in deceased patients.

BACKGROUND: To detect possible threats to quality and safety, multiple systems have been developed. One of them is retrospective chart review. A team of experts scrutinizes medical records, selected by trigger systems, to detect possible adverse events (AEs). The most important AEs and more hints for possible improvement of care appear in deceased patients. Using triggers in a sample of these patients might increase the performance and lower the burden of scrutinizing records without possible preventable AEs. The aim of this study was therefore to determine the performance of the trigger system in a sample of deceased patients and to calculate the specificity and the sensitivity of this trigger system for predicting AEs. METHODS: We performed a study in which the records of deceased patients were screened for triggers by a team of trained nurses. A sample of 100 medical records was randomly selected out of records which had been screened between 2012 and 2015 for the first time, prior to the study in 2016. For the determination of significant differences between the first and second screening, McNemar's test of symmetry was used. Also, observed agreement, Cohen's Kappa and prevalence-adjusted and-bias-adjusted-kappa (PABAK) statistics were calculated. This was done for the two trigger rounds on both any trigger present and for every trigger separately. RESULTS: The observed agreement for any given trigger was 75% with a Kappa and PABAK of 0.5. For the individual triggers, the observed agreement was on average 90%. The corresponding Kappa was on average 0.42 (range: - 0.03-0.78) and the average PABAK was 0.8 (range: 0.44-0.92). Two adverse events were found in cases without triggers previously. The recalculated specificity and sensitivity for the original population were 58 and 92% respectively. CONCLUSIONS: For the reproducibility of triggers it seems that some perform better than others, but on average this is to our opinion suboptimal. The low specificity implies that many records are selected without AEs. This leads to a high false-positive rate making this labour-intensive record review process costly. Therefore, research for better and more expedient systems is required.

Variación biológica de Creatinina, Cistatina C y Tasa de Filtrado Glomerular Estimada a lo largo de 24 horas / Biological Variation of Creatinine, Cystatin C, and Estimated Glomerular Filtration Rate over 24 hours

Antecedentes: La tasa de filtración glomerular estimada (TFGe) es ampliamente utilizada en la práctica clínica. El presente estudio evaluó la variación biológica intraindividual (CVI) de diferentes ecuaciones de TFGe en sujetos con enfermedad renal crónica (ERC) y sin ERC. Los objetivos de este estudio fueron (a) determinar los perfiles de variación biológica durante 24 horas de creatinina, cistatina C y TFGe y (b) determinar si el CVI de la creatinina, la cistatina C y la TFGe cambia el deterioro de la filtración glomerular. Métodos: Se analizaron muestras de sangre cada hora de 37 individuos (17 sin ERC, 20 con ERC) durante 24 h. La creatinina (método enzimático) y la cistatina C se midieron usando un Cobas 8000 (Roche Diagnostics). La TFGe se estimó utilizando la Modificación de la Dieta en la Enfermedad Renal y la Colaboración de Epidemiología de la Enfermedad Renal Crónica basada en creatinina y/o cistatina C. Las muestras de plasma se almacenaron a -80 °C antes del análisis. Se verificaron los análisis de valores atípicos y de homogeneidad antes de realizar un ANOVA anidado para determinar la variación biológica. Resultados: La CVI de creatinina fue más alta en sujetos sin ERC que en aquellos con ERC (6.4% frente a 2.5%) debido principalmente al efecto más marcado del consumo de carne sobre la variabilidad de creatinina en individuos con concentraciones iniciales de creatinina más bajas. A diferencia de la creatinina, las concentraciones de cistatina C no se vieron afectadas por el consumo de carne. La cistatina C mostró alguna variación rítmica diurna y menor en los sujetos con ERC. Los valores de referencia del cambio (VCR) de todas las ecuaciones de TFGe estuvieron dentro del 13% al 20% en ambos grupos de estudio. Conclusiones: A pesar de las diferencias en el CVI de la creatinina, el CVI y el VRC de las ecuaciones de TFGe fueron relativamente similares para los sujetos con o sin ERC.

Background: Estimated glomerular filtration rate (eGFR) is widely used in clinical practice. This study assessed the within-subject biological variation (CVI) of different eGFR equations in people with chronic kidney disease (CKD) and people without CKD. The aims of this study were (a) to determine the 24-h biological variation profiles of creatinine, cystatin C, and eGFR and (b) to determine whether CVI of creatinine, cystatin C, and eGFR changes on deterioration of glomerular filtration. Methods: Hourly blood samples were analyzed from 37 individuals (17 without CKD, 20 with CKD) during 24 h. Creatinine (enzymatic method) and cystatin C were measured using a Cobas 8000 (Roche Diagnostics). eGFR was estimated using the Modification of Diet in Renal Disease and the Chronic Kidney Disease Epidemiology Collaboration based on creatinine and/or cystatin C. Plasma samples were stored at -80 °C before analysis. Outlier and homogeneity analyses were checked before performing a nested ANOVA to determine biological variation. Results: CVI of creatinine was higher in people without CKD than in those with CKD (6.4% vs. 2.5%) owing primarily to the more profound effect of meat consumption on creatinine variability in individuals with lower baseline creatinine concentrations. Unlike creatinine, cystatin C concentrations were unaffected by meat consumption. Cystatin C showed some diurnal rhythmic variation and less in people with CKD. Reference change values (RCVs) of all eGFR equations were within 13% to 20% in both study groups. Conclusions: Despite differences in CVI of creatinine, the CVI and RCV of the eGFR equations were relatively similar for people with or without CKD.

Adverse event detection by medical record review is reproducible, but the assessment of their preventability is not.

OBJECTIVE: To assess the reproducibility of adverse event evaluation by a medical record review committee. DESIGN: Cross-sectional reanalysis of medical records. INTERVENTION: Reviewers re-examined fifty medical records of deceased patients regarding the presence of adverse events, their potential preventability and their possible contribution to death. Also we investigated the root causes of the preventable AEs. Differences between the first and second assessment were calculated. RESULTS: The Kappa on the presence of an adverse event was 0.64 and 0.32 for the potential preventability. The intrarater agreement showed a Kappa of 0.61 on the adverse event presence and 0.64 for the potential preventability. Interrater agreement showed a Kappa of 0.66 for the adverse event presence and 0.03 for the potential preventability. CONCLUSION: We found a fair reproducibility for the detection of adverse events, but a poor reproducibility for the potential preventability. Possibly this was caused by lack of a definition for the preventability of adverse events. We think giving feedback to professionals using the results of medical record review remains valuable, but an improvement of its reproducibility is essential. To our opinion an international consensus on what exactly constitutes preventability of adverse events and agreement on a definition is necessary. This would result in more comparable studies in this field and could then be more informative on the ideal procedure to avoid certain potentially preventable adverse events in the future.

Evaluation of Safety Guidelines on the Use of Iodinated Contrast Material: Conundrum Continued.

OBJECTIVES: Recently, safety guidelines for the use of intravascular iodinated contrast material have been updated, and the recommended threshold for giving prophylaxis to prevent contrast-induced nephropathy (CIN) has been reduced to estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m. Data on this population in the context of CIN, especially evidence for efficacy of the recommendation of prophylactic intravenous hydration, are lacking. The aim of the current study was to test implicit assumptions underlying the guideline update: (1) patients with eGFR <30 mL/min/1.73 m, as opposed to former high-risk patients with eGFR ≥30 mL/min/1.73 m, are at high risk of CIN and other unfavorable outcomes after intravascular iodinated contrast material administration; (2) prophylactic intravenous hydration mitigates this risk; and (3) the risk of administering prophylactic intravenous hydration does not outweigh the positive preventive effect. MATERIALS AND METHODS: Retrospectively, data were collected from all patients with eGFR <30 mL/min/1.73 m referred for an elective procedure with intravascular iodinated contrast material administration and excluded from the AMACING trial (A MAastricht Contrast-Induced Nephropathy Guideline trial). We compared these patients with those prospectively included in the AMACING trial (with eGFR 30-59 mL/min/1.73 m and risk factors). Main outcomes were CIN (defined as an increase in serum creatinine by more than 25% or 44 µmol/L within 2-6 days postcontrast exposure), dialysis and mortality within 35 days postcontrast exposure, and complications of prophylactic intravenous hydration. RESULTS: A total of 28,803 patients referred for an elective procedure with intravascular iodinated contrast administration were prospectively screened for inclusion in the AMACING trial. One hundred fifty-seven (0.5%) patients had eGFR <30 mL/min/1.73 m, and 155 received intravascular iodinated contrast material. Standard prophylaxis was given to 119/155 of these patients. Data on 2- to 6-day serum creatinine, 35-day dialysis 35-day mortality, and complications of prophylactic intravenous hydration were available for 59/119 (50%), 118/119 (99%), 119/119 (100%), and 119/119 (100%) standard prophylaxis patients, respectively. Incidences in eGFR <30 mL/min/1.73 m versus AMACING patients are as follows: CIN 13.6% versus 2.7% (P = 0.0019); 35-day dialysis 0.9% versus 0.0% (P = 0.2646); 35-day mortality 9.2% versus 0.0% (P < 0.0001); complications of prophylactic intravenous hydration 5.9% versus 5.5% (P = 0.8529). CONCLUSIONS: Postcontrast incidences of CIN and mortality at 35 days are significantly higher in the population with eGFR <30 mL/min/1.73 m than in the former high-risk population with eGFR 30 to 59 mL/min/1.73 m, even after prophylactic intravenous hydration. The risk of complications of prophylactic intravenous hydration is similar and substantial in both populations. Obtaining evidence from a randomized trial that efficacy of prophylactic intravenous hydration outweighs the risk of complications is important but may not be feasible.

Biological Variation of Creatinine, Cystatin C, and eGFR over 24 Hours.

BACKGROUND: Estimated glomerular filtration rate (eGFR) is widely used in clinical practice. This study assessed the within-subject biological variation (CVI) of different eGFR equations in people with chronic kidney disease (CKD) and people without CKD. The aims of this study were (a) to determine the 24-h biological variation profiles of creatinine, cystatin C, and eGFR and (b) to determine whether CVI of creatinine, cystatin C, and eGFR changes on deterioration of glomerular filtration. METHODS: Hourly blood samples were analyzed from 37 individuals (17 without CKD, 20 with CKD) during 24 h. Creatinine (enzymatic method) and cystatin C were measured using a Cobas 8000 (Roche Diagnostics). eGFR was estimated using the Modification of Diet in Renal Disease and the Chronic Kidney Disease Epidemiology Collaboration based on creatinine and/or cystatin C. Plasma samples were stored at -80 °C before analysis. Outlier and homogeneity analyses were checked before performing a nested ANOVA to determine biological variation. RESULTS: CVI of creatinine was higher in people without CKD than in those with CKD (6.4% vs 2.5%) owing primarily to the more profound effect of meat consumption on creatinine variability in individuals with lower baseline creatinine concentrations. Unlike creatinine, cystatin C concentrations were unaffected by meat consumption. Cystatin C showed some diurnal rhythmic variation and less in people with CKD. Reference change values (RCVs) of all eGFR equations were within 13% to 20% in both study groups. CONCLUSIONS: Despite differences in CVI of creatinine, the CVI and RCV of the eGFR equations were relatively similar for people with or without CKD.

Prophylactic Intravenous Hydration to Protect Renal Function From Intravascular Iodinated Contrast Material (AMACING): Long-term Results of a Prospective, Randomised, Controlled Trial.

BACKGROUND: The aim of A MAastricht Contrast-Induced Nephropathy Guideline (AMACING) trial was to evaluate non-inferiority of no prophylaxis compared to guideline-recommended prophylaxis in preventing contrast induced nephropathy (CIN), and to explore the effect on long-term post-contrast adverse outcomes. The current paper presents the long-term results. METHODS: AMACING is a single-centre, randomised, parallel-group, open-label, phase 3, non-inferiority trial in patients with estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m2 combined with risk factors, undergoing elective procedures requiring intravenous or intra-arterial iodinated contrast material. Exclusion criteria were eGFR < 30 mL/min/1.73 m2, dialysis, no referral for prophylaxis. The outcomes dialysis, mortality, and change in renal function at 1 year post-contrast were secondary outcomes of the trial. Subgroup analyses were performed based on pre-defined stratification risk factors. AMACING is registered with ClinicalTrials.gov: NCT02106234. FINDINGS: From 28,803 referrals, 1120 at-risk patients were identified. 660 consecutive patients agreed to participate and were randomly assigned (1:1) to no prophylaxis (n = 332) or standard prophylactic intravenous hydration (n = 328). Dialysis and mortality data were available for all patients. At 365 days post-contrast dialysis was recorded in two no prophylaxis (2/332, 0.60%), and two prophylaxis patients (2/328, 0.61%; p = 0.9909); mortality was recorded for 36/332 (10.84%) no prophylaxis, and 32/328 (9.76%) prophylaxis patients (p = 0.6490). The hazard ratio was 1.118 (no prophylaxis vs prophylaxis) for one-year risk of death (95% CI: 0.695 to 1.801, p = 0.6449). The differences in long-term changes in serum creatinine were small between groups, and gave no indication of a disadvantage for the no-prophylaxis group. INTERPRETATION: Assuming optimal contrast administration, not giving prophylaxis to elective patients with eGFR 30-59 mL/min/1.73 m2 is safe, even in the long-term. FUNDING: Stichting de Weijerhorst.

The ability of triggers to retrospectively predict potentially preventable adverse events in a sample of deceased patients.

Several trigger systems have been developed to screen medical records of hospitalized patients for adverse events (AEs). Because it's too labor-intensive to screen the records of all patients, usually a sample is screened. Our sample consists of patients who died during their stay because chances of finding preventable AEs in this subset are highest. Records were reviewed for fifteen triggers (n = 2182). When a trigger was present, the records were scrutinized by specialized medical doctors who searched for AEs. The positive predictive value (PPV) of the total trigger system and of the individual triggers was calculated. Additional analyses were performed to identify a possible optimization of the trigger system. In our sample, the trigger system had an overall PPV for AEs of 47%, 17% for potentially preventable AEs. More triggers present in a record increased the probability of detecting an AE. Adjustments to the trigger system slightly increased the positive predictive value but missed about 10% of the AEs detected with the original system. In our sample of deceased patients the trigger system has a PPV comparable to other samples. However still, an enormous amount of time and resources are spent on cases without AEs or with non-preventable AEs. Possibly, the performance could be further improved by combining triggers with clinical scores and laboratory results. This could be promising in reducing the costly and labor-intensive work of screening medical records.

Labtracker+, a medical smartphone app for the interpretation of consecutive laboratory results: an external validation study.

OBJECTIVES: When monitoring patients over time, clinicians may struggle to distinguish 'real changes' in consecutive blood parameters from so-called natural fluctuations. In practice, they have to do so by relying on their clinical experience and intuition. We developed Labtracker+, a medical app that calculates the probability that an increase or decrease over time in a specific blood parameter is real, given the time between measurements. DESIGN: We presented patient cases to 135 participants to examine whether there is a difference between medical students, residents and experienced clinicians when it comes to interpreting changes between consecutive laboratory results. Participants were asked to interpret if changes in consecutive laboratory values were likely to be 'real' or rather due to natural fluctuations. The answers of the study participants were compared with the calculated probabilities by the app Labtracker+ and the concordance rates were assessed. SETTING AND PARTICIPANTS: Medical students (n=92), medical residents from the department of internal medicine (n=19) and internists (n=24) at a Dutch University Medical Centre. PRIMARY AND SECONDARY OUTCOME MEASURES: Concordance rates between the study participants and the calculated probabilities by the app Labtracker+ were compared. Besides, we tested whether physicians with clinical experience scored better concordance rates with the app Labtracker+ than inexperienced clinicians. RESULTS: Medical residents and internists showed significantly better concordance rates with the calculated probabilities by the app Labtracker+ than medical students, regarding their interpretation of differences between consecutive laboratory results (p=0.009 and p<0.001, respectively). CONCLUSION: The app Labtracker+ could serve as a clinical decision tool in the interpretation of consecutive laboratory test results and could contribute to rapid recognition of parameter changes by physicians.