Status:
RECRUITING
The Acute Burn ResUscitation Multicenter Prospective Trial
Lead Sponsor:
American Burn Association
Collaborating Sponsors:
United States Department of Defense
Conditions:
Burn Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acut...
Detailed Description
Enrolled subjects will be randomly assigned to either the Colloid Group or the Crystalloid Group. Randomization will be based on an intent-to-treat basis. In order to ensure that the two groups have c...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Total burn size (second and third degree) is ≥ 25% of the TBSA
- Burn center admission within 12 hours of injury.
- There is a plan for formal fluid resuscitation.
Exclusion
- Significant associated trauma
- High voltage (≥ 1000 volts) electrical burns
- Burn wound excision surgery within 48 hours from injury
- Fresh frozen plasma (FFP) given at any time ≤ 48 hours from injury
- Hypertonic saline (HTS) given at any time ≤ 48 hours from injury
- Hydroxyethyl starch (HES) given at any time ≤ 48 hours from injury
- High dose Vitamin C infusion given at any time ≤ 48 hours from injury
- Administration of human albumin prior to randomization
- Palliative comfort measures are instituted ≤ 48 hours from injury
- Pregnancy
- Pre-injury chronic renal insufficiency equal to or greater than stage 3
- Pre-injury chronic hepatic disease (Child-Pugh B or C)
- Pre-injury left ventricular (LV) dysfunction (echocardiography LV grade II-IV or ejection fraction ≤ 35%)
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04356859
Start Date
April 22 2021
End Date
September 1 2025
Last Update
February 1 2024
Active Locations (26)
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1
Arizona Burn Center Valleywise Health
Phoenix, Arizona, United States, 85008
2
University of California Davis, Regional Burn Center
Sacramento, California, United States, 95817
3
Torrance Memorial
Torrance, California, United States, 90505
4
University of Florida Health
Gainesville, Florida, United States, 32608