REstrictive versus StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to PICU: a pilot randomized...

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.