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

Inclusion Criteria4

Trauma patients older than 6 months and younger than 15 years admitted to the pediatric intensive care unit (PICU)
Patients admitted to the PICU directly from the Emergency Department (ED)
Patients admitted to the PICU from the operating room (OR)
Patients transferred to PICU from outside facility ED (need to have been in ED 12 hours or less)

Exclusion Criteria11

Patients transferred to PICU from outside PICU or inpatient floor
Patients transferred to PICU from outside facility ED if \>12 hours
Patients expected to be discharged from the PICU within 24 hours
Patient with congenital heart disease as defined by a congenital cardiac defect requiring surgery or medication
Patient with diagnosis of chronic cardiac condition (e.g. hypertension, cardiac arrhythmia)
Patients with chronic kidney disease as defined by an abnormality of kidney structure or function, present for more than 3 months, with implications to health
Post-operative transplant, cardiac, and neurosurgical patients
Patients with traumatic brain injury
Patients with any disease that may affect baseline blood pressure and heart rate (endocrine disorders, certain genetic disorders, mitochondrial diseases)
Hypotension requiring vasopressor therapy
If massive transfusion protocol initiated

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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.