Dataset Information

The timing of continuous renal replacement therapy initiation in sepsis-associated acute kidney injury in the intensive care unit: the CRTSAKI Study (Continuous RRT Timing in Sepsis-associated AKI in ICU): study protocol for a multicentre, randomised controlled trial.

ABSTRACT:

Introduction

Acute kidney injury (AKI) is one of the most common organ dysfunction in sepsis, and increases the risk of unfavourable outcomes. Renal replacement therapy (RRT) is the predominant treatment for sepsis-associated AKI (SAKI). However, to date, no prospective randomised study has adequately addressed whether initiating RRT earlier will attenuate renal injury and improve the outcome of sepsis. The objective of the trial is to compare the early strategy with delayed strategy on the outcomes in patients with SAKI in the intensive care unit (ICU).

Methods and analysis

This is a large-scale, multicentre, randomised controlled trial about SAKI. In total, 460 patients with sepsis and evidence of AKI stage 2 of Kidney Disease Improving Global Outcomes (KDIGO) will be recruited and equally randomised into the early group and the delay group in a ratio of 1:1. In the early group, continuous RRT (CRRT) will be started immediately after randomisation. In the delay group, CRRT will initiated if at least one of the following criteria was met: stage 3 of KDIGO, severe hyperkalaemia, pulmonary oedema, blood urea nitrogen level higher than 112?mg/dL after randomisation. The primary outcome is overall survival in a 90-day follow-up period (90-day all-cause mortality). Other end points include 28-day, 60-day and 1-year mortality, recovery rate of renal function by day 28 and day 90, ICU and hospital length of stay, the numbers of CRRT-free days, mechanical ventilation-free days and vasopressor-free days, the rate of complications potentially related to CRRT, CRRT-related cost, and concentrations of inflammatory mediators in serum.

Ethics and dissemination

The trial has been approved by the Clinical Research and Application Institutional Review Board of the Second Affiliated Hospital of Guangzhou Medical University (2017-31-ks-01). Participants will be screened and enrolled from patients in the ICU with SAKI by clinicians, with no public advertisement for recruitment. Results will be disseminated in research journals and through conference presentations.

Trial registration

NCT03175328.

SUBMITTER: Chen WY

PROVIDER: S-EPMC7896624 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

The timing of continuous renal replacement therapy initiation in sepsis-associated acute kidney injury in the intensive care unit: the CRTSAKI Study (Continuous RRT Timing in Sepsis-associated AKI in ICU): study protocol for a multicentre, randomised controlled trial.

Chen Wei-Yan WY Cai Li-Hua LH Zhang Zhen-Hui ZH Tao Li-Li LL Wen Yi-Chao YC Li Zhi-Bo ZB Li Li L Ling Yun Y Li Jian-Wei JW Xing Rui R Liu Xue-Yan XY Lin Zhuan-di ZD Deng Zhe-Tong ZT Wang Shou-Hong SH Lin Qin-Han QH Zhou Dun-Rong DR He Zhi-Jie ZJ Xiong Xu-Ming XM

BMJ open 20210219 2

<h4>Introduction</h4>Acute kidney injury (AKI) is one of the most common organ dysfunction in sepsis, and increases the risk of unfavourable outcomes. Renal replacement therapy (RRT) is the predominant treatment for sepsis-associated AKI (SAKI). However, to date, no prospective randomised study has adequately addressed whether initiating RRT earlier will attenuate renal injury and improve the outcome of sepsis. The objective of the trial is to compare the early strategy with delayed strategy on ...[more]

PMID: 33608398

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Project description:IntroductionInitiating dialysis in acute kidney injury (AKI) in an intensive care unit (ICU) remains a subjective clinical decision. We examined factors and practice patterns that influence early initiation of dialysis in ICU patients with acute kidney injury.MethodsAn online survey presented nephrologists (international) with three case scenarios with unstated predicted mortality rates of < 10%, 10 - 30% and > 30%. For each case the respondents were asked 4 questions about influences on the decision whether or not to initiate dialysis within 24 hours: Q1, likelihood of initiating dialysis; Q2, threshold of BUN levels (< 50, 50 - 75, 76 - 100, > 100 mg/dl) considered relevant to this decision; Q3, magnitude of creatinine elevation (two to three-fold increase; greater than threefold increase; absolute level > 5 mg/dl regardless of change) considered relevant; Q4, a rank order of the influence of five parameters (BUN level, change of creatinine from baseline, oxygen saturation, potassium level, and urine output), 1 being the most influential and 5 being the least influential.ResultsOne hundred seventy-two nephrologists (73% in practice for > 5 years; 70% from the U.S.A.) responded to the survey. The proportion of subjects likely to initiate early dialysis increased (76% to 94%), as did the predicted mortality (p < 0.001). The proportion of subjects considering early dialysis at a BUN level ? 75 increased from 17% to 30 to 40% as the predicted mortality of the cases increased (p < 0.0001). The proportion of subjects choosing absolute creatinine level to be more influential than relative increment, went from 60% to 54% to 43% as predicted mortality increased (p < 0.0001). Rank-order analysis indicated that influence of oxygen saturation and potassium level on dialysis decision showed a significant change with severity of illness, but BUN level and creatinine elevation remained less influential, and did not change with severity.ConclusionsSeverely ill patients were more likely to be subjected to early dialysis initiation, but its utility is not clear. Rank-order analysis indicates dialysis initiation is still influenced by "imminent" indications rather than a "proactive" decision based on the severity of AKI or azotemia.

Project description:BACKGROUND AND OBJECTIVES:Literature on the prognosis of patients with cirrhosis who require RRT for AKI is sparse and is confounded by liver transplant eligibility. An update on outcomes in the nonlisted subgroup is needed. Our objective was to compare outcomes in this group between those diagnosed with hepatorenal syndrome and acute tubular necrosis, stratifying by liver transplant listing status. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:Retrospective cohort study of patients with cirrhosis acutely initiated on hemodialysis or continuous RRT at five hospitals, including one liver transplant center. Multivariable regression and survival analysis were performed. RESULTS:Four hundred seventy-two subjects were analyzed (341 not listed and 131 listed for liver transplant). Among nonlisted subjects, 15% (51 of 341) were alive at 6 months after initiating RRT. Median survival was 21 (interquartile range [IQR], 8, 70) days for those diagnosed with hepatorenal syndrome and 12 (IQR, 3, 43) days for those diagnosed with acute tubular necrosis (P=0.25). Among listed subjects, 48% (63 of 131) received a liver transplant. Median transplant-free survival was 15 (IQR, 5, 37) days for those diagnosed with hepatorenal syndrome and 14 (IQR, 4, 31) days for those diagnosed with acute tubular necrosis (P=0.60). When stratified by transplant listing, with adjusted Cox models we did not detect a difference in the risk of death between hepatorenal syndrome and acute tubular necrosis (hazard ratio [HR], 0.81; 95% confidence interval [95% CI], 0.59 to 1.11, among those not listed; HR, 0.73; 95% CI, 0.44 to 1.19, among those listed). CONCLUSIONS:Cause of AKI was not significantly associated with mortality in patients with cirrhosis who required RRT. Among those not listed for liver transplant, mortality rates were extremely high in patients both with hepatorenal syndrome and acute tubular necrosis. PODCAST:This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2017_11_09_CJASNPodcast_18_1_A.mp3.

Project description:Background and objectivesAKI is associated with short- and long-term mortality. However, the exact contribution of AKI complications to the burden of mortality and whether RRT has any beneficial effect on reducing mortality rates in critically ill AKI patients are unknown.Design, setting, participants, & measurementsThis was a retrospective analysis using data from the Multiparameter Intelligent Monitoring in Intensive Care II project. A total of 18,410 adult patients were enrolled from four intensive care units from a university hospital from 2001 to 2008.ResultsOverall, 10,245 patients developed AKI. After adjustments, the odds ratios (ORs) for hospital mortality were 1.73 (95% confidence interval [95% CI], 1.52 to 1.98) for AKI stage 1, 1.88 (95% CI, 1.57 to 2.25) for stage 2, and 2.89 (95% CI, 2.41 to 3.46) for stage 3. Totals of 33%, 59%, and 70% of the excess mortality rates associated with AKI stages 1, 2, and 3, respectively, were attenuated by the inclusion of each AKI-related complication in the model. The main burden of excess hospital mortality associated with AKI was attenuated by metabolic acidosis and cumulative fluid balance. Long-term mortality was not attenuated by any of the associated complications. Next, we used two different approaches to explore the associations between RRT, AKI complications, and hospital mortality: multivariate analysis and propensity score matching. In both approaches, the sensitivity analysis for RRT was associated with a better hospital survival in only the following AKI-related subgroups: hyperkalemia (OR, 0.55; 95% CI, 0.35 to 0.85), metabolic acidosis (OR, 0.70; 95% CI, 0.53 to 0.92), cumulative fluid balance >5% of body weight (OR, 0.60; 95% CI, 0.40 to 0.88), and azotemia (OR, 0.57; 95% CI, 0.40 to 0.81).ConclusionsA majority of the excess risk of mortality associated with AKI was attenuated by its fluid volume and metabolic complications, particularly in severe AKI. In addition, this study demonstrated that RRT is associated with a better outcome in patients with AKI-related complications.

Project description:Rationale & objectiveContinuous kidney replacement therapy (CKRT) is the predominant form of acute kidney replacement therapy used for critically ill adult patients with acute kidney injury (AKI). Given the variability in CKRT practice, a contemporary understanding of its epidemiology is necessary to improve care delivery.Study designMulticenter, prospective living registry.Setting & population1,106 critically ill adults with AKI requiring CKRT from December 2013 to January 2021 across 5 academic centers and 6 intensive care units. Patients with pre-existing kidney failure and those with coronavirus 2 infection were excluded.ExposureCKRT for more than 24 hours.OutcomesHospital mortality, kidney recovery, and health care resource utilization.Analytical approachData were collected according to preselected timepoints at intensive care unit admission and CKRT initiation and analyzed descriptively.ResultsPatients' characteristics, contributors to AKI, and CKRT indications differed among centers. Mean (standard deviation) age was 59.3 (13.9) years, 39.7% of patients were women, and median [IQR] APACHE-II (acute physiologic assessment and chronic health evaluation) score was 30 [25-34]. Overall, 41.1% of patients survived to hospital discharge. Patients that died were older (mean age 61 vs. 56.8, P < 0.001), had greater comorbidity (median Charlson score 3 [1-4] vs. 2 [1-3], P < 0.001), and higher acuity of illness (median APACHE-II score 30 [25-35] vs. 29 [24-33], P = 0.003). The most common condition predisposing to AKI was sepsis (42.6%), and the most common CKRT indications were oliguria/anuria (56.2%) and fluid overload (53.9%). Standardized mortality ratios were similar among centers.LimitationsThe generalizability of these results to CKRT practices in nonacademic centers or low-and middle-income countries is limited.ConclusionsIn this registry, sepsis was the major contributor to AKI and fluid management was collectively the most common CKRT indication. Significant heterogeneity in patient- and CKRT-specific characteristics was found in current practice. These data highlight the need for establishing benchmarks of CKRT delivery, performance, and patient outcomes. Data from this registry could assist with the design of such studies.

Project description:BackgroundCoronavirus disease 2019 (COVID-19) may predispose patients to thrombotic events. The best anticoagulation strategy for continuous renal replacement therapy (CRRT) in such patients is still under debate. The purpose of this study was to evaluate the impact that different anticoagulation protocols have on filter clotting risk.MethodsThis was a retrospective observational study comparing two different anticoagulation strategies (citrate only and citrate plus intravenous infusion of unfractionated heparin) in patients with acute kidney injury (AKI), associated or not with COVID-19 (COV + AKI and COV - AKI, respectively), who were submitted to CRRT. Filter clotting risks were compared among groups.ResultsBetween January 2019 and July 2020, 238 patients were evaluated: 188 in the COV + AKI group and 50 in the COV - AKI group. Filter clotting during the first filter use occurred in 111 patients (46.6%). Heparin use conferred protection against filter clotting (HR = 0.37, 95% CI 0.25-0.55), resulting in longer filter survival. Bleeding events and the need for blood transfusion were similar between the citrate only and citrate plus unfractionated heparin strategies. In-hospital mortality was higher among the COV + AKI patients than among the COV - AKI patients, although it was similar between the COV + AKI patients who received heparin and those who did not. Filter clotting was more common in patients with D-dimer levels above the median (5990 ng/ml). In the multivariate analysis, heparin was associated with a lower risk of filter clotting (HR = 0.28, 95% CI 0.18-0.43), whereas an elevated D-dimer level and high hemoglobin were found to be risk factors for circuit clotting. A diagnosis of COVID-19 was marginally associated with an increased risk of circuit clotting (HR = 2.15, 95% CI 0.99-4.68).ConclusionsIn COV + AKI patients, adding systemic heparin to standard regional citrate anticoagulation may prolong CRRT filter patency by reducing clotting risk with a low risk of complications.

Dataset Information

The timing of continuous renal replacement therapy initiation in sepsis-associated acute kidney injury in the intensive care unit: the CRTSAKI Study (Continuous RRT Timing in Sepsis-associated AKI in ICU): study protocol for a multicentre, randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration

Publications

The timing of continuous renal replacement therapy initiation in sepsis-associated acute kidney injury in the intensive care unit: the CRTSAKI Study (Continuous RRT Timing in Sepsis-associated AKI in ICU): study protocol for a multicentre, randomised controlled trial.

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