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REstrictive versus StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to PICU: a pilot randomized
Sainath Raman1,2, Sarfaraz Rahiman2, Melanie Kennedy2
1Children's Intensive Care Research Program, Child Health Research Centre, University of Queensland, Brisbane, QLD, Australia.
Insights
A pilot study found that a restrictive intravenous (IV) fluid strategy in pediatric intensive care unit (PICU) patients was not feasible for a full trial. Current designs need modification for future research on fluid management in critically ill children.
Area of Science:
- Pediatric Critical Care Medicine
- Clinical Trial Design
- Fluid Management
Background:
- Fluid overload is a significant concern in pediatric intensive care unit (PICU) patients, correlating with adverse outcomes.
- Assessing the feasibility of alternative fluid management strategies is crucial for improving patient care.
Purpose of the Study:
- To evaluate the feasibility of conducting a randomized controlled trial (RCT) comparing restrictive intravenous (IV) fluid administration with usual care in PICU patients.
- To determine the recruitment rate and adherence to the restrictive fluid protocol.
Main Methods:
- A pilot, parallel-arm, open-label randomized controlled trial (RCT) was conducted in two Australian and one Swiss PICUs.
- Mechanically ventilated children (<18 years) were randomized to either a restrictive IV fluid strategy or usual care for 48 hours.
- The restrictive strategy involved lower maintenance fluids, smaller boluses, less drug dilution, and earlier use of diuretics or peritoneal dialysis.
Main Results:
- The trial failed to meet its target recruitment rate, enrolling 158 of 1224 eligible patients (67% consent rate).
- No patients in the restrictive group achieved a negative fluid balance >10% body weight within 24 hours, versus 6% in the usual care group.
- Median fluid balance at 48 hours was similar between groups (11.1 mL/kg restrictive vs. 8.6 mL/kg usual care).
Conclusions:
- The current restrictive IV fluid management protocol (REDUCE-1) is not feasible for a full-scale RCT in mechanically ventilated children.
- Future research may necessitate refined intervention protocols or bundled care approaches to improve feasibility.
- This pilot study highlights challenges in recruiting for pediatric critical care trials.
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.
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