Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients: A Multicenter Randomized Controlled Trial
Columbia University
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.
Description
Aggressive fluid resuscitation has been the cornerstone of early post-operative and trauma management for decades. However, recent prospective adult studies have challenged this practice, linking high volume crystalloid resuscitation to increased mortality, cardiopulmonary, gastrointestinal and hematologic complications. A retrospective study the investigators recently performed at their quaternary-care children's hospital echoed these results. High quality prospective data is necessary to determine best practice guidelines in our pediatric surgery and trauma patients. Currently, no standard…
Eligibility
- Age range
- 0–15 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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…
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 BuffaloBuffalo, New York
- Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's HospitalNew York, New York
- University of Rochester, Golisano Children's HospitalRochester, New York
- Le Bonheur Children's HospitalMemphis, Tennessee