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RECRUITING
NCT04201704
NA

Effect of Giving Reduced Fluid in Children After Trauma

Sponsor: Columbia University

View on ClinicalTrials.gov

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

OTHER

Balanced crystalloid solution volume administration

Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.

OTHER

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.

OTHER

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.

OTHER

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