Effect of Giving Reduced Fluid in Children After Trauma

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.

Conditions

• Critical Illness
• Pediatrics
• General Surgery
• Fluid Therapy
• Wounds and Injuries

Interventions

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.

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

Balanced crystalloid solution volume administration

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

Sponsors & Collaborators

• Northwell Health

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Cornell University

  collaborator OTHER

• Childress Institute for Pediatric Trauma

  collaborator UNKNOWN

• Columbia University

  lead OTHER

Principal Investigators

• Vincent P Duron, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-27

Primary Completion

2027-08-31

Completion

2027-09-30

Countries

• United States

Study Locations