Abstract

Background: Fluid overload is common in critically ill children and is associated with adverse outcome. Therefore, restricting fluid intake may be beneficial. This study aims to study the feasibility of a randomized controlled trial (RCT) comparing a conservative to a standard, more liberal, strategy of fluid management in mechanically ventilated pediatric patients with acute respiratory tract infection (ARTI).Methods: This is a feasibility study in a single, tertiary referral pediatric intensive care unit (PICU). Twenty-three children receiving mechanical ventilation for ARTI, without ongoing hemodynamic support, admitted to the PICU of the Emma Children's Hospital/Amsterdam UMC between 2016 and 2018 were included. Patients were randomized to a conservative (<70% of normal intake) or standard (>85% of normal intake) fluid strategy, which was kept throughout the period of mechanical ventilation.Results: Primary endpoints were adherence to fluid strategy and safety parameters such as calorie and protein intake. Secondary outcomes were cumulative fluid intake (CFI) and cumulative fluid balance (CFB) on day 3. In the conservative group, in 75% of the mechanical ventilation days patients achieved their target fluid intake. Median [25th−75th percentiles] calorie intake over all mechanical ventilation days was 67.9 [51.5–74.0] kcal/kg/day in the conservative vs. 67.2 [58.0–75.2] kcal/kg/day in the standard group (p = 0.878). Protein intake was 1.6 [1.3–1.8] gr protein/kg in the conservative and 1.5 [1.2–1.7] gr protein/kg in the standard group (p = 0.598). No adverse effects on hemodynamics or electrolyte imbalances were noted. Mean (±SD) CFI on day 3 was 262.3 (±58.9) ml/kg in the conservative group vs. 360.5 (±52.6) ml/kg in the standard fluid group (p < 0.001), which did not result in a lower CFB.Conclusions: A conservative fluid strategy in mechanically ventilated children with ARTI seems feasible, without limiting metabolic needs. However, in our study a conservative fluid strategy surprisingly did not reduce the degree of fluid overload. This study aids the design and sample size calculation of a future larger multicenter RCT, in which we need to redefine the target fluid strategy, possibly by even further fluid restriction and early initiation of active diuresis.Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT02989051.

Highlights

  • Fluid overload is common in critically ill children and is associated with adverse outcome

  • Twenty four patients gave their consent for inclusion, but one patient did not start the study protocol due to referral to another hospital

  • There was no significant difference between fluid strategies in oxygenation failure over time, as measured by oxygen saturation index (OSI). In this single center feasibility study we investigated the feasibility of conducting a large-scale trial comparing the current standard, more liberal, fluid maintenance strategy to a conservative fluid strategy during mechanical ventilation in critically ill pediatric patients with acute respiratory tract infection (ARTI)

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Summary

Introduction

Fluid overload is common in critically ill children and is associated with adverse outcome. This study aims to study the feasibility of a randomized controlled trial (RCT) comparing a conservative to a standard, more liberal, strategy of fluid management in mechanically ventilated pediatric patients with acute respiratory tract infection (ARTI). Numerous studies have shown that—in both adults and children—fluid overload, or extreme positive cumulative fluid balance (CFB), has adverse effects on outcome, such as a longer duration of mechanical ventilation and even higher mortality rates [2, 5,6,7,8]. A large randomized controlled trial (RCT) in adult acute respiratory distress syndrome patients has shown a conservative fluid management regimen to lead to more ventilator-free days [9, 10]. Along with the logistical difficulty of reaching adequate study sample sizes, these issues together raise the need for feasibility studies in critically ill children

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