The Efficient PICU Fluid Care Evaluation (NCT06644508) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Efficient PICU Fluid Care Evaluation
Netherlands90 participantsStarted 2024-10
Plain-language summary
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
Who can participate
Age range
10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Cardiovascular (including diuretics) drug use on admission (home medication)
* Pre-existent (clinical) diagnosis of liver failure
* Right of left heart failure
* Pulmonary hypertension
* ECMO treatment
* Receiving total parenteral nutrition on admission which won't be stopped
* Failure to include within 12 hours after start of IMV
* Expected duration of IMV \< 48 hours
* Parents or caretakers unable to understand/speak Dutch language
* Surgery \< 48 hours
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative fluid balance on day 3 in ml/kg
Timeframe: From start mechanical ventilation to 72 hours after start of mechanical ventilation