Actively Recruiting

Phase Not Applicable
Age: 6Months - 15Years
All Genders
NCT04201704

Effect of Giving Reduced Fluid in Children After Trauma

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

250

Participants Needed

4

Research Sites

470 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

Northwell Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is designed to help decide how much intravenous (IV) fluid should be given to pediatric trauma patients. No standard currently exists for managing fluids in critically ill pediatric trauma patients, and many fluid strategies are now in practice. For decades, trauma patients got high volumes of IV fluid. Recent studies in adults show that patients actually do better by giving less fluid. The investigators do not know if this is true in children and this study is designed to answer that question and provide guidelines for IV fluid management in children after trauma.

CONDITIONS

Official 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 (need to 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 >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

AI-Screening

AI-Powered Screening

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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

CONTACT

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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