Critical Illness Clinical Trial
Official title:
Fluids in Mechanically Ventilated Children With Acute Infectious Lung Disease: How Dry Should They be?
Rationale: Fluid overload is a common complication in children who are admitted to the
pediatric intensive care for mechanical ventilation. Acute lung infection is a frequent
cause for admission to the PICU and forms an uniform group with a single organ failure. In
these critically ill children, fluid overload is associated with adverse outcome.
Restricting the volume of fluids already in an early stage of ICU admission may prevent
fluid overload during mechanical ventilation and thus improve clinical outcome. However, at
the same time fluid restriction may interfere with appropriate energy and macronutrient
intake that is needed for recovery.
Objective: The main goal of this pilot study is to evaluate the feasibility of a restrictive
fluid management protocol and investigate its effect on the occurrence of fluid overload in
mechanically ventilated children with acute infectious lung disease.
Study design: Single-center prospective randomized feasibility and pilot study in
preparation of a multi-center randomized controlled trial (RCT).
Study population: Mechanically ventilated children with (suspicion of) acute infectious lung
disease admitted to the pediatric intensive care unit (PICU) of the Emma Children's
Hospital, Academic Medical Center, Amsterdam.
Intervention: Patients receive either liberal (control group) or a restrictive (experimental
group) fluid treatment, while ensuring appropriate caloric intake.
Main study parameters/endpoints: Primary outcomes are cumulative fluid balance and body
weight during the first week of mechanical ventilation. Secondary outcomes (in preparation
of the larger multi-center RCT) include: mortality, duration of mechanical ventilation and
oxygenation indices. To determine the feasibility, in- and exclusion rate, adherence to
treatment arms, need for fluid bolus, need for diuretics and hemodynamic indices as well as
energy and protein intake are studied.
Both fluid management protocols reflect a variant of current clinical practice, hence will
not provide extra burden or risk to patients included in the study. Patients will be
randomized to either of the fluid protocol arms on admission to the PICU (at start of
mechanical ventilation). Patients included in the restrictive fluid treatment arm might have
direct benefit from the study if indeed fluid overload is less common in this group.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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