LESS IS MORE? – A PILOT RCT OF FLUID STRATEGY IN CRITICALLY ILL CHILDREN WITH ACUTE RESPIRATORY TRACT INFECTION
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 pilot the feasibility of a RCT comparing a conservative to a standard, more liberal, strategy of fluid management in mechanically ventilated (MV) pediatric patients with acute respiratory tract infection (ARTI). Methods: This is a pilot RCT and feasibility study in a single, tertiary referral pediatic intensive care unit. Twenty-three children receiving MV for ARTI, without ongoing hemodynamic support, admitted to the PICU of the Emma Children’s Hospital/Amsterdam UMC between 2016-2018 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 MV. 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 MV days patients reached their target fluid intake. Median calorie intake over all MV days was 67.8 [53.1-75.2] kcal/kg/day and 1.6 [1.3-1.7] gr protein/kg/day (no difference between groups). No adverse effects on hemodynamics or electrolyte imbalances were noted. Mean 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 MV 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 pilot 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. Trial registration: ClinicalTrials.gov, NCT02989051. Registered 12 December 2016 - Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/NCT02989051