The Efficient PICU Fluid Care Evaluation
Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Oct 14, 2024
Trial Information
Current as of July 21, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The Efficient PICU Fluid Care Evaluation is a clinical trial aimed at helping critically ill children who need support for their breathing through machines, known as mechanical ventilation. The main focus of this study is to see if giving less fluid (a restrictive fluid strategy) can help prevent fluid overload, which can be harmful for these young patients. Researchers will compare this careful approach to the usual practices at hospitals to see which one works better in keeping the children safe and healthy during their treatment.
To be eligible for the trial, children must be under 10 years old, weigh less than 35 kg, and require mechanical ventilation due to serious breathing problems. They should be expected to need this support for more than 48 hours. During the study, participants will receive care for up to ten days while on mechanical ventilation, or until they are discharged from the intensive care unit. It's important to note that parents or caregivers should be able to understand and communicate in Dutch to participate. This study will help improve how we care for children with breathing difficulties in the future.
Gender
ALL
Eligibility criteria
- 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
About Radboud University Medical Center
Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nijmegen, Gelderland, Netherlands
Rotterdam, Zuid Holland, Netherlands
Amsterdam, Noord Holland, Netherlands
Patients applied
Trial Officials
Joris Lemson, MD PhD
Principal Investigator
Radboud University Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported