An interventional study of Balanced crystalloid solution volume administration and Packed Erythrocytes Units, Blood Product Unit volume in Critical Illness, Pediatrics and General Surgery, sponsored by Columbia University. Recruiting at 4 sites in United States. Open to participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Columbia University · Not applicable, Interventional, and Supportive care
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.
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 exists to guide management of crystalloid fluid administration in trauma patients. Both liberal and restricted strategies are in use, dependent on physician discretion. The investigators propose the first randomized controlled trial (RCT) comparing a liberal to a restricted fluid management strategy in critically ill pediatric trauma patients. The objective of this comparative effectiveness study is to conduct a multicenter (around 10 sites) randomized controlled trial (RCT) to determine whether liberal or restricted fluid administration leads to better outcomes in these patients.
Exclusion Criteria:
* 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
Other: Balanced crystalloid solution volume administration · Other: Packed Erythrocytes Units, Blood Product Unit volume · Other: Plasma volume · Other: Platelets volume
* 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
Other: Balanced crystalloid solution volume administration · Other: Packed Erythrocytes Units, Blood Product Unit volume · Other: Plasma volume · Other: Platelets volume
Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
Also known as: lactated ringers
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.
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.
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.
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: Up to time of discharge (up to approximately 1 month)
Number of Hours of Hospital Length of Stay
length of time in hospital to inpatient discharge in hours
Time frame: Up to time of discharge (up to approximately 1 month)
Number of Hours of ICU Length of Stay
length of time in pediatric intensive care unit in hours
Time frame: Up to time of discharge (up to approximately 1 month)
Number of hours on Supplemental Oxygen
length of time patient requires non-invasive supplemental O2 in hours
Time frame: Up to time of discharge (up to approximately 1 month)
Number of Hours on Ventilator
length of time patient requires invasive ventilation in hours
Time frame: Up to time of discharge (up to approximately 1 month)
Plan to share: No
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