RecruitingNot ApplicableNCT04201704

Effect of Giving Reduced Fluid in Children After Trauma

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

Sponsor

Columbia University

Enrollment

250 participants

Start Date

Aug 27, 2018

Study Type

INTERVENTIONAL

Conditions

Pediatrics General Surgery Wounds and Injuries Critical Illness Fluid Therapy

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.

Eligibility

Min Age: 6 MonthsMax Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Balanced crystalloid solution volume administration, Packed Erythrocytes Units, Blood Product Unit volume, and others for people with critical illness, fluid therapy, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 6 Months to 15 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBalanced crystalloid solution volume administration

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

OTHERPacked 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.

OTHERPlasma 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.

OTHERPlatelets 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.