Determining the best IV fluid amount for children after trauma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to establish optimal intravenous fluid management for pediatric trauma patients by comparing liberal versus restricted fluid administration strategies. Given the lack of standardized guidelines for fluid therapy in critically ill children, this randomized controlled trial will involve multiple centers and assess outcomes related to fluid volume in trauma cases. The study is motivated by recent findings in adult populations suggesting that less fluid may lead to better outcomes, and seeks to determine if similar results apply to children. By generating high-quality prospective data, the study hopes to inform best practices in pediatric trauma care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Trauma patients older than 6 months and younger than 15 years admitted to the pediatric intensive care unit (PICU)
* Patients admitted to the PICU directly from the Emergency Department (ED)
* Patients admitted to the PICU from the operating room (OR)
* Patients transferred to PICU from outside facility ED (need to have been in ED 12 hours or less)

Exclusion Criteria:

* Patients transferred to PICU from outside PICU or inpatient floor
* Patients transferred to PICU from outside facility ED if \>12 hours
* Patients expected to be discharged from the PICU within 24 hours
* Patient with congenital heart disease as defined by a congenital cardiac defect requiring surgery or medication
* Patient with diagnosis of chronic cardiac condition (e.g. hypertension, cardiac arrhythmia)
* Patients with chronic kidney disease as defined by an abnormality of kidney structure or function, present for more than 3 months, with implications to health
* Post-operative transplant, cardiac, and neurosurgical patients
* Patients with traumatic brain injury
* Patients with any disease that may affect baseline blood pressure and heart rate (endocrine disorders, certain genetic disorders, mitochondrial diseases)
* Hypotension requiring vasopressor therapy
* If massive transfusion protocol initiated

Where it's running

• Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital
  New York, New York, United States Recruiting
• University of Rochester, Golisano Children's Hospital
  Rochester, New York, United States Recruiting
• Le Bonheur Children's Hospital
  Memphis, Tennessee, United States Recruiting
• John R. Oishei Children's Hospital of Buffalo
  Buffalo, New York, United States Not yet recruiting

Study contacts

• Principal investigator: Vincent P Duron, MD — Columbia University
• Study coordinator: Vincent P Duron, MD
• Email: vd2312@cumc.columbia.edu
• Phone: 212-342-8586

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.