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)
Clinical Snapshot
PICO Framework
| P — Population | Hemodynamically stable mechanically ventilated children in pediatric intensive care unit |
| I — Intervention | Protocolized restrictive maintenance fluid strategy (40-50% of maintenance fluids with diuretic infusion if FO% > 10%) |
| C — Comparator | Liberal/usual maintenance fluid strategy (70-80% of maintenance fluid) |
| O — Outcomes | Primary: proportion of children with cumulative fluid overload > 10% through day 5. Secondary: daily cumulative FO%, ∆IVC, NT-proBNP levels, safety parameters, 28-day ventilator-free days, PICU-free days, and mortality |
Bottom Line
This open-label RCT demonstrates that a protocolized restrictive maintenance fluid strategy (40-50% of maintenance fluids with diuretics if fluid overload >10%) significantly reduces fluid overload compared to liberal fluid management (70-80% maintenance) in hemodynamically stable mechanically ventilated children. The restrictive approach reduced the proportion of children with fluid overload >10% from 47% to 22% (NNT=4) without compromising safety or short-term clinical outcomes. While the open-label design introduces bias risk, the large effect size and clinical relevance of fluid overload reduction make this a compelling intervention for pediatric intensive care. The strategy appears safe and feasible for implementation in Australian PICUs, though longer-term outcome data would strengthen the evidence base.
Key Findings
P Value: p = 0.003 for primary outcome
Effect Size: Absolute risk reduction of 25% for fluid overload >10%
Primary Outcome: Proportion with cumulative fluid overload >10%: 22% restrictive vs 47% liberal/usual
Nnt Or Sensitivity: Number needed to treat = 4 (to prevent one case of fluid overload >10%)
Confidence Interval: Not reported in abstract
Clinical Application
Highly feasible as intervention involves standard fluid management protocols and commonly available diuretics Directly applicable to Australian PICUs. Aligns with contemporary pediatric critical care practices. No specific PBS or TGA considerations as uses standard fluid management approaches. Hemodynamically stable mechanically ventilated children in pediatric intensive care units
Abstract
UNLABELLED: 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). CONCLUSION: 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. WHAT IS KNOWN: • Fluid overload (FO) is associated with poor clinical outcomes among critically ill mechanically ventilated children. WHAT IS NEW: • 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.
References
- 1.John, S. M., Angurana, S. K., Muralidharan, J., Bansal, A., Nallasamy, K., & Ram, S. (2026). 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). European Journal of Pediatrics. https://doi.org/10.1007/s12098-025-05478-x
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