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Search / Trial NCT06644508

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

Respiratory Insufficiency Mechanical Ventilation Fluids Fluid Balance Edema Fluid Overload Lenght Of Mechanical Ventilation Childeren Maintenance Fluids

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.

Locations

Nijmegen, Gelderland, Netherlands

Rotterdam, Zuid Holland, Netherlands

Amsterdam, Noord Holland, Netherlands

Patients applied

0 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