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

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 study is examining whether giving children less intravenous (IV) fluid after a traumatic injury leads to better outcomes compared to standard fluid amounts. Trauma is a leading cause of death and disability in children, and how much fluid is given during recovery can affect healing, organ function, and recovery time. Researchers believe that reducing fluid given in the pediatric intensive care unit (PICU) may help prevent complications like fluid overload, which can stress the heart, kidneys, and lungs. This study will carefully compare outcomes between children who receive reduced fluids versus those who receive the usual amount. You may be eligible if: - Your child is between 6 months and 15 years old - Your child was admitted to the PICU directly after trauma from the emergency department or operating room - Your child was transferred from an outside emergency department within 12 hours You may NOT be eligible if: - Your child has congenital heart disease requiring surgery or medication - Your child has a chronic cardiac condition (e.g., hypertension, arrhythmia) - Your child has chronic kidney disease - Your child has a traumatic brain injury - Your child requires vasopressors for low blood pressure - A massive transfusion protocol has been started - Your child is expected to be discharged from the PICU within 24 hours Talk to your doctor to see if this trial is right for you.

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.


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

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NCT04201704


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