Determining the best IV fluid amount for children after trauma
Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients: A Multicenter Randomized Controlled Trial
This study is testing whether giving more or less IV fluid to children after a trauma helps them recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 6 Months to 15 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 4 sites (Buffalo, New York and 3 other locations) |
| Trial ID | NCT04201704 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are trauma patients aged 6 months to 15 years who are admitted to the pediatric intensive care unit.
Not a fit: Patients with congenital heart disease, chronic cardiac conditions, or chronic kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes for pediatric trauma patients through better fluid management.
How similar studies have performed: Other studies in adult populations have shown success with similar fluid management approaches, but this is the first of its kind in pediatric trauma.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Buffalo, New York and 3 other locations
- John R. Oishei Children's Hospital of Buffalo — Buffalo, New York, United States (Not_yet_recruiting)
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.