Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT04201704

Conditions

Critical Illness

Pediatrics

General Surgery

Fluid Therapy

Wounds and Injuries

Eligibility Criteria

Sex: All

Age: 0 - 15

Healthy Volunteers: Not accepted

Interventions

Balanced crystalloid solution volume administration

Packed Erythrocytes Units, Blood Product Unit volume

Plasma volume

Platelets volume

Study Details

Brief 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.

Conditions

Critical Illness

Pediatrics

General Surgery

Fluid Therapy

Wounds and Injuries

Study ID

NCT04201704

Start date

Aug 27, 2018

Status verified date

May, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 15

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Liberal 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

experimental: Restricted IV Fluid

  • 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

Interventions

Balanced crystalloid solution volume administration

Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.

Packed 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.

Plasma 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.

Platelets 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.

Primary outcome measure

  • Overall complications [ Time Frame: Up to time of discharge (up to approximately 1 month) ]

Central Contacts and Locations

Central contacts

Vincent P Duron, MD

212-342-8586vd2312@cumc.columbia.edu

Locations

Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Vincent P Duron, MD

212-342-8586vd2312@cumc.columbia.edu

University of Rochester, Golisano Children's Hospital

Recruiting

Rochester, New York, United States, 14642

Le Bonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

More Information

Sponsor

Columbia University

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-05-07.