Effect of Giving Reduced Fluid in Children After Trauma

Part of paid clinical trials in Buffalo, New York.

Sponsor
Columbia University
Study ID
NCT04201704
Status
Recruiting
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Conditions

  • Critical Illness
  • Fluid Therapy
  • General Surgery
  • Pediatrics
  • Wounds and Injuries

Eligibility Criteria

Sex
ALL
Age
6 Months - 15 Years
Healthy Volunteers
Not accepted

Interventions

  • Balanced crystalloid solution volume administration — OTHER
    Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
  • Packed Erythrocytes Units, Blood Product Unit volume — OTHER
    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
    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
    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.

Study Details

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.

Key Dates

Start date
Aug 27, 2018
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
John R. Oishei Children's Hospital of BuffaloBuffaloNew York14203
Shahzad Waheed, MD
[email protected]
Andrew Nordin, MD
[email protected]
Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's HospitalNew YorkNew York10032
Vincent P Duron, MD
[email protected]
212-342-8586
University of Rochester, Golisano Children's HospitalRochesterNew York14642
David Darcy
Le Bonheur Children's HospitalMemphisTennessee38103
Regan F Williams, MD, MS

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By research site
John R. Oishei Children's Hospital of Buffalo· Buffalo, NYColumbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital· New York, NYUniversity of Rochester, Golisano Children's Hospital· Rochester, NYLe Bonheur Children's Hospital· Memphis, TN

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