REstrictive versus StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to PICU: a pilot randomized controlled trial (REDUCE-1).

OBJECTIVE

Fluid overload in PICU patients is associated with poor outcome. In 2021 we aimed to assess the feasibility of a randomized controlled trial (RCT) of restrictive IV fluid vs. usual IV fluids.

DESIGN

Pilot, parallel-arm, open-label RCT (Australian New Zealand Clinical Trials Registry, ACTRN12621001311842).

SETTING

Two PICUs in Australia and one in Switzerland.

PATIENTS: During 2021-2023, we recruited PICU patients aged younger than 18 years who were expected to be invasively ventilated or were already ventilated for greater than 6 hours.

INTERVENTIONS: Patients were randomly allocated to either a restrictive IV fluid strategy or usual care for 48 hours. The restrictive strategy included lower maintenance fluid, smaller fluid boluses and less drug dilution, and earlier diuretics or peritoneal dialysis.

MEASUREMENTS AND MAIN

RESULTS

Of 1224 eligible patients, 235 parents were approached and 158 consented (i.e., 67%, one child excluded postrandomization; median [interquartile range, IQR] age was 1.3 yr [IQR 0.3, 7.0]), which meant that the trial did not meet the a priori target recruitment rate. The mean ( sd ) number of patients recruited per month was 6.8 ( sd 3.6). None of 80 patients recruited to the restrictive strategy attained a negative fluid balance greater than10% body weight within 24 hours, compared with 5/77 (6%) in the usual care arm. Median fluid balance at 48 hours postrandomization was 11.1 (IQR -13.7, 40.2) and 8.6 mL/kg (IQR -18.7, 38.8) in the restrictive strategy and usual care, respectively. Median survival free of the PICU for restrictive and usual care was, respectively: 25.0 days (IQR 21.3, 26.0) vs. 24.0 days (IQR 22.1, 26.0).

CONCLUSIONS

This 2021-2023 pilot RCT shows that the restrictive vs. standard fluid management in mechanically ventilated children (REDUCE-1) protocol would not be feasible if extended to a full RCT, as currently designed. Future approaches may require stricter guidance regarding the intervention, or use of bundled care.