Restricted versus Usual/Liberal Maintenance Fluid Strategy in Mechanically Ventilated Children: An Open-Label Randomized Trial (ReLiSCh Trial)

Objectives: To assess the impact of restricted vs. usual/liberal maintenance fluid strategy on fluid overload (FO) among mechanically ventilated children. Methods: This open-label randomized controlled trial was conducted over a period of 1 y (October 2020-September 2021) in a Pediatric intensive care unit (PICU) in North India. Hemodynamically stable mechanically ventilated children were randomized to 40% (restricted group, n = 50) and 70-80% (usual/liberal group, n = 50) of maintenance fluids. The primary outcome was cumulative fluid overload percentage (FO%) on day 7. Secondary outcomes were FO% >10%; vasoactive inotropic score, sequential organ failure assessment score, pediatric logistic organ dysfunction score and oxygenation index from day 1-7; ventilation free days (VFDs) and PICU free days (PFDs) through day 28; and mortality. Results: The restricted group had statistically non-significant trend towards lower cumulative FO% at day 7 [7.6 vs. 9.5, p = 0.40]; and proportion of children with FO% >10% (12% vs. 26%, p = 0.21) as compared to usual/liberal group. The increase in FO% from day 1-7 was significant in usual/liberal group as compared to restricted group (p <0.001 and p = 0.134, respectively). Restricted group received significantly lower amount of fluid in the first 5 d; had significantly higher VFDs (23 vs. 17 d, p = 0.008) and PFDs (19 vs. 15 d, p = 0.007); and trend towards lower mortality (8% vs. 16%, p = 0.21). Conclusions: Restricted as compared to usual/liberal maintenance fluid strategy among mechanically ventilated children was associated with a trend towards lower rate and severity of FO and mortality; and significantly lower fluid volume received, and higher VFDs and PFDs.