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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Strict adherence to European guidelines
Other interventionThe goal is to maintain a neutral fluid balance throughout the course of intubation if clinical practice allows. Therefore: * From the start of mechanical ventilation, the maximum maintenance fluids is 65% of the maintenance fluids proposed by the Holliday \& Segar formula. Fluid resuscitation in the first hours after intubation is at the discretion of the attending physician. * Any other interventions to maintain a neutral fluid balance (e.g., starting diuretics, reducing fluid boluses, decreasing creep fluids, or using more concentrated enteral feeding) are at the discretion of the attending physician. * Throughout the intervention, the attending physician decides if clinical practice allows for a decrease in fluid balance, and international feeding goals must always be met.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Observation of current local practicesNo intervention 0 interventions
Group B: Strict adherence to european guidelinesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative fluid balance on day 3 in ml/kg
Cumulative fluid balance (CFB) over the course of three days after the start of mechanical ventilation is noted in ml/kg. CFB is calculated as a sum of daily (fluid intake \[liters\] - total output \[liters\])/ body weight (kilograms).
Time frame
From start mechanical ventilation to 72 hours after start of mechanical ventilationSecondary outcomes
1
Daily cumulative fluid balance on in ml/kg
Daily cumulative fluid balance (CFB) over the course of mechanical ventilation is noted in ml/kg. CFB is calculated as a sum of daily (fluid intake \[liters\] - total output \[liters\])/ body weight (kilograms).
Time frame
For 10 days, CFB is noted every day at 00:002
Protein intake in gr/kg/day
Protein intake in gr/kg/day will be daily noted
Time frame
For ten days after start of mechanical ventilation3
Bodyweight in grams
Bodyweight in grams
Time frame
Bodyweight in grams will be measured at start of mechanical ventilation and at 72 hours after start of mechanical ventilation4
Daily cumulative diuretics dose in mg/kg
Cumulative diuretics dose will be daily noted in mg/kg.
Time frame
From start of mechnical ventilation for ten days, cumulative diuretic dose will be noted at 00:00Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: