The Efficient PICU Fluid Care Evaluation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 10
SponsorRadboud University Medical Center

About this trial

The goal of this clinical trial is to evaluate and prevent fluid overload in critically ill, mechanically ventilated children. The main questions it aims to answer are:

1. What is the effect of a restrictive fluid strategy on cumulative fluid balance on day three of invasive mechanical ventilation? 2. What is the feasibility (e.g. adherence to target intake, fluid balance and nutritional goals) of maintaining a neutral fluid balance?

Researchers will compare the effects of strict adherence to the European Society of Paediatric and Neonatal Intensive Care (ESPNIC) guidelines regarding fluid balance (i.e. restricting fluid intake and preventing a positive fluid balance) to current local practice.

From the start to the end of invasive mechanical ventilation participants will be treated according to local practice or with the strict aim to prevent a positive fluid balance. Aiming to prevent a positive fluid balance, if this is possible given the clinical context, is at descretion of the attending physician. Minimal caloric intake requirements must be met.

Participants are studied for ten days during invasive mechanical ventilation or until discharge from the intensive care

Eligibility criteria

Qualifiers

Age < 10 years and weight < 35 kg

Receiving invasive mechanical ventilation (IMV) due to respiratory failure

Inclusion possible within 24 hours of start of IMV

Expected duration of IMV > 48 hours

Disqualifiers

Preterm (<37weeks gestational age)

Preexistent (clinical) diagnosis of kidney disease

Congenital cardiac defect with hemodynamic consequences or reduced cardiac function

(Ongoing) shock with need for fluid resuscitation and/or vasoactive drugs

Trial design

Treatments tested in this trial

  • Strict adherence to European guidelines

Treatment groups

90 Participants
are divided into 2 treatment groups