Actively Recruiting

Phase Not Applicable
Age: 6Months - 15Years
All Genders
ID04201704

Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients: A Multicenter Randomized Controlled Trial

Led by Columbia University · Updated on 2026-05-07

250

Participants Needed

4

Research Sites

4 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

Northwell Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how much intravenous (IV) fluid should be given to critically ill pediatric trauma patients. The study aims to compare two fluid management strategies—liberal versus restricted fluid administration—to determine which leads to better outcomes. This research addresses the lack of a standard approach to fluid resuscitation in children after trauma, building on adult studies suggesting that giving less fluid may improve results. This randomized controlled trial involves around 10 centers and compares two fluid strategies in children aged between 6 months and 15 years admitted to pediatric intensive care units after trauma. One group receives fluids based on a standard maintenance rate calculated by weight, with larger boluses given if certain clinical criteria are met. The other group receives reduced fluid volumes calculated at 70% of the standard maintenance rate, with correspondingly smaller boluses. Transfusions of blood products are given as needed based on specific clinical thresholds. Fluid rates may be adjusted over time according to urine output and other measures. Participants will be closely monitored during their hospital stay, with researchers tracking overall complications up to discharge, which is typically within about one month. Other outcomes include length of hospital and ICU stay, time on supplemental oxygen, and time on a ventilator. The study uses clinical data, vital signs, and lab results to guide fluid management and assess safety. Participation duration depends on hospital stay length, with detailed assessments throughout the intensive care period.

CONDITIONS

Brief Title

Effect of Giving Reduced Fluid in Children After Trauma

Who Can Participate

Age: 6Months - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (must have been in ED 12 hours or less)
Not Eligible

You will not qualify if you...

  • Patients transferred to PICU from outside PICU or inpatient floor
  • Patients transferred to PICU from outside facility ED if more than 12 hours
  • Patients expected to be discharged from the PICU within 24 hours
  • Patients with congenital heart disease requiring surgery or medication
  • Patients with chronic cardiac conditions such as hypertension or arrhythmia
  • Patients with chronic kidney disease present for more than 3 months
  • Post-operative transplant, cardiac, and neurosurgical patients
  • Patients with traumatic brain injury
  • Patients with diseases affecting baseline blood pressure and heart rate (e.g., endocrine, genetic, mitochondrial disorders)
  • Patients with hypotension requiring vasopressor therapy
  • Patients if massive transfusion protocol has been initiated

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - Up to approximately 1 month or until hospital discharge

Participants receive either a liberal or restricted intravenous fluid management strategy based on randomized assignment to support their recovery after trauma in the pediatric intensive care unit.

Continuous care during hospital stay with clinical monitoring

Trial Site Locations

Total: 4 locations

1

John R. Oishei Children's Hospital of Buffalo

Buffalo, New York, United States, 14203

Not Yet Recruiting

2

Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital

New York, New York, United States, 10032

Actively Recruiting

3

University of Rochester, Golisano Children's Hospital

Rochester, New York, United States, 14642

Actively Recruiting

4

Le Bonheur Children's Hospital

Memphis, Tennessee, United States, 38103

Actively Recruiting

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Research Team

V

Vincent P Duron, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Fluid balance, complications, and brain tissue oxygen tension monitoring following severe traumatic brain injury.

Jeffrey J Fletcher, Karen Bergman, Paul A Blostein...

https://pubmed.ncbi.nlm.nih.gov/20376708

Fluid overload before continuous hemofiltration and survival in critically ill children: a retrospective analysis.

Jason A Foland, James D Fortenberry, Barry L Warshaw...

https://pubmed.ncbi.nlm.nih.gov/15286557

Aggressive early crystalloid resuscitation adversely affects outcomes in adult blunt trauma patients: an analysis of the Glue Grant database.

George Kasotakis, Antonis Sideris, Yuchiao Yang...

https://pubmed.ncbi.nlm.nih.gov/23609270