Effect of Giving Reduced Fluid in Children After Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorColumbia University
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Balanced crystalloid solution volume administration
- Packed Erythrocytes Units, Blood Product Unit volume
- Plasma volume
- Platelets volume
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
Northwell Health
Collaborator
Johns Hopkins University
Collaborator
Cornell University
Collaborator
Childress Institute for Pediatric Trauma
Collaborator
Source ClinicalTrials.gov