Restrictive fluid management with early de-escalation versus usual care in critically ill patients (reduce trial): a feasibility randomized controlled trial

Abstract

Optimal fluid management in critically ill patients varies across different phases of care. This study examined the feasibility of adding a restrictive fluid strategy with early de-escalation to standard care for patients with circulatory shock. We performed a single-center, feasibility, randomized controlled trial, involving patients with shock who required fluid resuscitation and were admitted in the medical intensive care unit. After initial fluid resuscitation, patients were randomly assigned (1:1) to either a restrictive fluid strategy or usual care. The restrictive group targeted a near-zero fluid balance over 3 days by limiting fluid intake and using diuretics or mechanical fluid removal when needed. The primary outcome was cumulative fluid balance at day 3. The secondary outcomes were the lengths of stay in the intensive care unit and the hospital, the mechanical ventilation duration, acute kidney injury, renal replacement therapy, and mortality. We enrolled 100 patients, assigning 50 to the restrictive strategy and 50 to usual care. By day 3, the restrictive group showed a lower cumulative fluid balance than usual care (‒2353 mL vs. 793 mL, p < 0.001). This trend continued to day 7 (‒3032 mL vs. 1125 mL, p < 0.001). The restrictive group also had shorter stays in the intensive care unit and the hospital (7 vs. 10 days, p = 0.006; 16 vs. 22 days, p = 0.02). There were no statistically significant differences in hospital or 30-day mortality rates between the groups (18% vs. 38%, p = 0.05; 12% vs. 30%, p = 0.05, respectively). Similarly, no significant differences were observed in the incidence of acute kidney injury or the use of renal replacement therapy. A restrictive fluid strategy with early de-escalation and de-resuscitation is feasible and may reduce fluid accumulation and showed a signal for reduced hospital stay without increasing adverse events in critically ill patients following acute fluid resuscitation. TCTR20220719002 (The trial has been reviewed and approved by TCTR committee on July 16th, 2022). A restrictive fluid strategy that employs a protocol-based intervention to achieve a target fluid balance after initial resuscitation in patients with sepsis appears feasible, does not increase harm, and may improve outcomes.