Effect of Giving Reduced Fluid in Children After Trauma
Critical Illness, Pediatrics, General Surgery
About this trial
This is an interventional supportive care trial for Critical Illness focused on measuring Fluid Therapy, Intensive Care Units, Pediatric, Critical Care, Wounds and Injuries, Multiple Trauma, Treatment Outcome, Postoperative Complications, Resuscitation, Hemodynamics, Infusions, Intravenous, Isotonic Solutions, Crystalloid Solutions, Diuretics, Organism Hydration Status, Body Water
Eligibility Criteria
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
- 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
Sites / Locations
- Johns Hopkins University Charlotte R. Bloomberg Children's Center
- Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's HospitalRecruiting
- Northwell Health Cohen Children's Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Liberal IV Fluid
Restricted IV Fluid
Maintenance fluid rate calculated by 4-2-1 formula for patients <110kg: 4 mL/kg for first 0-10kg + 2 mL/kg for 11-20kg + 1 mL/kg for each kg >20kg Patients >110kg maintenance 150 mL/hr Bolus Criteria: change in 1 of: >20% decrease in systolic blood pressure 50th percentile for age and sex, >20% increase in heart rate over 50th percentile for age, base excess > -5mmol/L, blood lactate >2mmol/L, AND urine output (UO) <1 mL/kg/hr if <50kg or <50 mL/hr if >50kg If criteria met: bolus 20 mL/kg if <50kg or 1 L if ≥50 kg For transfusion: give 10 mL/kg packed red blood cells, platelets, or fresh frozen plasma up to 250 mL. If >25kg give 250 mL. Diuresis- after minimum 24hrs: if UO <2 mL/kg/hr (or <100 mL/hr if >50 kg) continue maintenance rate and bolus per initial phase. If UO >2 mL/kg/hr (or >100 mL/hr if >50kg), and lactate, systolic blood pressure, heart rate, creatinine are normal then lower IV fluid rate to ½ maintenance rate and then to "keep vein open" once on regular feeds
Maintenance fluid rate calculated by 70% of 4-2-1 formula if <110 kg: 4 mL/kg for first 0-10 kg, + 2 mL/kg for 11-20 kg, + 1 mL/kg for every kg >20 kg Patients >110 kg: maintenance is 105 mL/hr If same bolus criteria met: 10 mL/kg for patients <50kg, or 500 mL if ≥50 kg If meet transfusion criteria: transfuse 10 mL/kg with packed red blood cells, platelets, or fresh frozen plasma by weight up to 250 mL. Patients >25 kg get 250 mL per transfusion Diuresis (after minimum 24 hrs): if UO <1 mL/kg/hr (or <50 mL/hr if >50 kg) then continue IV fluids at maintenance rate and bolus as needed. If UO 1-2 mL/kg/hr (or 50-100 mL/hr if >50 kg) then decrease IV rate to ½ maintenance rate. If UO >2 mL/kg/hr (or >100 mL/hr if >50 kg), and Lactate, systolic blood pressure, heart rate, creatinine normal then reduce to "keep vein open" and consider Furosemide for goal UO >2-4 mL/kg/hr (100-200 mL/hr if >50 kg) until euvolemic