Immediate versus delayed fluid resuscitation for hypotensive patients with penetrating torso injuries.
W H Bickell, M J Wall, P E Pepe...
https://pubmed.ncbi.nlm.nih.gov/7935634Actively Recruiting
Led by Columbia University · Updated on 2026-05-07
250
Participants Needed
4
Research Sites
4 weeks
Total Duration
C
Columbia University
Lead Sponsor
N
Northwell Health
Collaborating Sponsor
Researchers are investigating how much intravenous (IV) fluid should be given to critically ill pediatric trauma patients. The study aims to compare two fluid management strategies—liberal versus restricted fluid administration—to determine which leads to better outcomes. This research addresses the lack of a standard approach to fluid resuscitation in children after trauma, building on adult studies suggesting that giving less fluid may improve results. This randomized controlled trial involves around 10 centers and compares two fluid strategies in children aged between 6 months and 15 years admitted to pediatric intensive care units after trauma. One group receives fluids based on a standard maintenance rate calculated by weight, with larger boluses given if certain clinical criteria are met. The other group receives reduced fluid volumes calculated at 70% of the standard maintenance rate, with correspondingly smaller boluses. Transfusions of blood products are given as needed based on specific clinical thresholds. Fluid rates may be adjusted over time according to urine output and other measures. Participants will be closely monitored during their hospital stay, with researchers tracking overall complications up to discharge, which is typically within about one month. Other outcomes include length of hospital and ICU stay, time on supplemental oxygen, and time on a ventilator. The study uses clinical data, vital signs, and lab results to guide fluid management and assess safety. Participation duration depends on hospital stay length, with detailed assessments throughout the intensive care period.
CONDITIONS
Effect of Giving Reduced Fluid in Children After Trauma
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to approximately 1 month or until hospital discharge
Participants receive either a liberal or restricted intravenous fluid management strategy based on randomized assignment to support their recovery after trauma in the pediatric intensive care unit.
Continuous care during hospital stay with clinical monitoring
Total: 4 locations
1
John R. Oishei Children's Hospital of Buffalo
Buffalo, New York, United States, 14203
Not Yet Recruiting
2
Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States, 10032
Actively Recruiting
3
University of Rochester, Golisano Children's Hospital
Rochester, New York, United States, 14642
Actively Recruiting
4
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Actively Recruiting
V
Vincent P Duron, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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