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Effect of Giving Reduced Fluid in Children After Trauma
Sponsor: Columbia University
Summary
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.
Official title: Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
6 Months - 15 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2018-08-27
Completion Date
2026-09
Last Updated
2025-05-04
Healthy Volunteers
No
Interventions
Balanced crystalloid solution volume administration
Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
Packed Erythrocytes Units, Blood Product Unit volume
For patients designated as Bleeding, where hemoglobin \<7 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.
Plasma volume
For patients designated as Bleeding, where International Normalized Ratio (INR) \> 1.5 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.
Platelets volume
For patients designated as Bleeding, where platelets \< 50,000 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.
Locations (4)
John R. Oishei Children's Hospital of Buffalo
Buffalo, New York, United States
Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States
University of Rochester, Golisano Children's Hospital
Rochester, New York, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States