Restrictive versus Liberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury (RELIEVE-AKI): a pilot clinical trial protocol

IntroductionObservational studies have linked slower and faster net ultrafiltration (UFNET) rates during kidney replacement therapy (KRT) with mortality in critically ill patients with acute kidney injury (AKI) and fluid overload. To inform the design of a larger randomised trial of patient-centered...

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Published in:BMJ open Vol. 13; no. 7; p. e075960
Main Authors: Murugan, Raghavan, Chang, Chung-Chou H, Raza, Maham, Nikravangolsefid, Nasrin, Huang, David T, Palevsky, Paul M, Kashani, Kianoush, Al-Khafaji, Ali, Butcher, Brad, Lamberty, Philip, Abdulmajeed, Firas, Gunn, Scott, Kattah, Andrea, Elder, Michele, Scholl, Denise, Sabol, William, Vita, Tina
Format: Journal Article
Language:English
Published: England British Medical Journal Publishing Group 07.07.2023
BMJ Publishing Group LTD
BMJ Publishing Group
Series:Protocol
Subjects:
Acute Kidney Injury - etiology
Acute renal failure
Adult intensive & critical care
Cardiac arrhythmia
Clinical outcomes
Clinical Trial
Clinical trials
Critical Illness
Decision making
Diabetes
Dialysis
Drug dosages
Drug overdose
Edema
Educational materials
Extracorporeal membrane oxygenation
Hemodynamics
Humans
Informed consent
Intensive Care
Intensive Care Units
Kidney diseases
Mortality
Observational studies
Outcome Assessment, Health Care
Patient-centered care
Patients
Randomized Controlled Trials as Topic
Renal Replacement Therapy
United States > US
Dialysis
Clinical Trial
Acute renal failure
Adult intensive & critical care
ISSN:2044-6055, 2044-6055
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Summary:IntroductionObservational studies have linked slower and faster net ultrafiltration (UFNET) rates during kidney replacement therapy (KRT) with mortality in critically ill patients with acute kidney injury (AKI) and fluid overload. To inform the design of a larger randomised trial of patient-centered outcomes, we conduct a feasibility study to examine restrictive and liberal approaches to UFNET during continuous KRT (CKRT).Methods and analysisThis study is an investigator-initiated, unblinded, 2-arm, comparative-effectiveness, stepped-wedged, cluster randomised trial among 112 critically ill patients with AKI treated with CKRT in 10 intensive care units (ICUs) across 2 hospital systems. In the first 6 months, all ICUs started with a liberal UFNET rate strategy. Thereafter, one ICU is randomised to the restrictive UFNET rate strategy every 2 months. In the liberal group, the UFNET rate is maintained between 2.0 and 5.0 mL/kg/hour; in the restrictive group, the UFNET rate is maintained between 0.5 and 1.5 mL/kg/hour. The three coprimary feasibility outcomes are (1) between-group separation in mean delivered UFNET rates; (2) protocol adherence; and (3) patient recruitment rate. Secondary outcomes include daily and cumulative fluid balance, KRT and mechanical ventilation duration, organ failure-free days, ICU and hospital length of stay, hospital mortality and KRT dependence at hospital discharge. Safety endpoints include haemodynamics, electrolyte imbalance, CKRT circuit issues, organ dysfunction related to fluid overload, secondary infections and thrombotic and haematological complications.Ethics and disseminationThe University of Pittsburgh Human Research Protection Office approved the study, and an independent Data and Safety Monitoring Board monitors the study. A grant from the United States National Institute of Diabetes and Digestive and Kidney Diseases sponsors the study. The trial results will be submitted for publication in peer-reviewed journals and presented at scientific conferences.Trial registration numberThis trial has been prospectively registered with clinicaltrials.gov (NCT05306964). Protocol version identifier and date: 1.5; 13 June 2023.
Bibliography:Protocol
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2023-075960