Restrictive fluid management versus usual care in acute kidney injury (REVERSE-AKI): a pilot randomized controlled feasibility trial

Abstract

Purpose: We compared a restrictive fluid management strategy to usual care among critically ill patients with acute kidney injury (AKI) who had received initial fluid resuscitation.Methods: This multicenter feasibility trial randomized 100 AKI patients 1:1 in seven ICUs in Europe and Australia. Restrictive fluid management included targeting negative or neutral daily fluid balance by minimizing fluid input and/or enhancing urine output with diuretics administered at the discretion of the clinician. Fluid boluses were administered as clinically indicated. The primary endpoint was cumulative fluid balance 72 h from randomization.Results: Mean (SD) cumulative fluid balance at 72 h from randomization was − 1080 mL (2003 mL) in the restrictive fluid management arm and 61 mL (3131 mL) in the usual care arm, mean difference (95% CI) − 1148 mL (− 2200 to − 96) mL, P = 0.033. Median [IQR] duration of AKI was 2 [1-3] and 3 [2-7] days, respectively (median difference − 1.0 [− 3.0 to 0.0], P = 0.071). Altogether, 6 out of 46 (13%) patients in the restrictive fluid management arm and 15 out of 50 (30%) in the usual care arm received renal replacement therapy (RR 0.42; 95% CI 0.16-0.91), P = 0.043. Cumulative fluid balance at 24 h and 7 days was lower in the restrictive fluid management arm. The dose of diuretics was not different between the groups. Adverse events occurred more frequently in the usual care arm. Conclusions:In critically ill patients with AKI, a restrictive fluid management regimen resulted in lower cumulative fluid balance and less adverse events compared to usual care. Larger trials of this intervention are justified.

Adjunctive ketamine for sedation in critically ill mechanically ventilated patients: an active-controlled, pilot, feasibility clinical trial

“…Those progression criteria were another critical decision in pilot sample size calculation. Thresholds were chosen after examining other pilot feasibility studies of complex interventions (defined as interventions with several interacting components) and summarized in Additional file 1 : Table S2 [ 25 – 27 ].…”

“…Sensitivity analysis for sedative and vasopressor requirements, excluding patients started on NMB post-randomization, was conducted. We also performed an additional post hoc sensitivity analysis in per-protocol population, defined as mITT population after exclusion of subjects who did not complete 48 h post-randomization [ 27 ]. We ensured immediate data entry and identified missing data quickly, and issues were resolved promptly.…”

A Positive Fluid Balance in the First Week Was Associated With Increased Long-Term Mortality in Critically Ill Patients: A Retrospective Cohort Study

“…However, the enrollment of both septic and non-septic should reflect the nature of this real-world study. Moreover, the relative neutral fluid balance among patients enrolled during 2015-2019 aligns with a shift toward more restrictive fluid management in critically ill patients reported in recent trials (27).…”

Feasibility of conservative fluid administration and deresuscitation compared with usual care in critical illness: the Role of Active Deresuscitation After Resuscitation-2 (RADAR-2) randomised clinical trial

“…The mortality rate in the intervention group is similar to that in other recent sepsis trials [31,32], while that in the standard care group is unexpectedly low. Furthermore, other recent trials in critically ill patients have suggested comparable or better outcomes resulting from restrictive fluid strategies [11,25,33]. The likelihood that this finding represents a type 1 error is, therefore, high.…”