Impact of protocolized restrictive versus liberal/usual maintenance fluid strategy on fluid overload among mechanically ventilated children: an open-label randomized trial (ReLiSCh-II trial).

Abstract / Summary

Fluid overload (FO) is associated with poor clinical outcomes among critically ill children. The objective of this trial was to assess the impact of a protocolized restrictive maintenance fluid strategy on FO among mechanically ventilated children. This open-label randomized controlled trial was conducted in the pediatric intensive care unit (PICU) of a tertiary care hospital in North India over 13 months (November 2023-November 2024). Hemodynamically stable mechanically ventilated children were randomized to protocolized restrictive (n = 64) (40-50% of maintenance fluids with diuretic infusion if FO% > 10%); and liberal/usual (n = 66) (70-80% of maintenance fluid) groups. The primary outcome was the proportion of children with cumulative FO% > 10% through day 5. Secondary outcomes were daily cumulative FO%; inferior vena cava variability index (∆IVC) and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels at 48 h; safety parameters (requirement of fluid boluses or vasoactive drugs); 28-day ventilator and PICU-free days (VFDs and PFDs), and mortality. Significantly fewer children in the protocolized restrictive group had cumulative FO% > 10% than in the liberal/usual group (22% vs. 47%, p = 0.003). Also, the restrictive group had significantly lower daily cumulative FO% on the first 5 days. ∆IVC and NT-proBNP levels at 48 h, as well as safety parameters, were similar between the two groups. Protocolized restrictive and liberal/usual groups had similar VFDs [20 (8-24) vs. 16 (0-23), p = 0.076], PFDs [16 (3-21) vs. 13 (0-19), p = 0.071], and mortality (14% vs. 24%, p = 0.14).  A protocolized restrictive maintenance fluid strategy resulted in significantly lower FO among hemodynamically stable, mechanically ventilated children without a measurable impact on short-term clinical outcomes. • Fluid overload (FO) is associated with poor clinical outcomes among critically ill mechanically ventilated children. • Among hemodynamically stable, mechanically ventilated children, a restrictive maintenance fluid strategy may be a useful intervention to limit FO and improve clinical outcomes in LMICs.

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