Effect of Giving Reduced Fluid in Children After Trauma

ConditionsCritical Illness Pediatrics General Surgery Fluid Therapy Wounds and Injuries

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Balanced crystalloid solution volume administration
Other intervention
Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
Packed Erythrocytes Units, Blood Product Unit volume
Other intervention
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.
Plasma volume
Other intervention
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.
Platelets volume
Other intervention
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.

Treatment groups

250 Participants

are divided into 2 treatment groups

Group A: Liberal IV FluidActive comparator 4 interventions

Group B: Restricted IV FluidExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

Overall complications

Total number of complications defined as pulmonary edema, hemorrhage, deep cavity infection, anastomotic dehiscence, thrombosis, death, superficial wound infection, ileus, and pneumonia.

Time frame