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The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)
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 acute burn involving at least 25% of their total body surface area.
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 comparable injury severity at baseline, randomization will be block- stratified based on age (18-50 and \> 50 years), burn size (25-50% and \> 50% TBSA), and presence of inhalation injury confirmed by bronchoscopy (present or absent). In the Colloid Group resuscitation starts with LR and then 5% albumin will be introduced between 8 and 12 hours post burn in a ratio of 1/3 albumin to 2/3 LR. In the Crystalloid Group resuscitation is with LR only. Each group will have their study fluid maintained for the 1st 48 hours post burn and study fluids in each group will be identically titrated to the urinary output.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Arizona Burn Center Valleywise Health
Phoenix, Arizona, United States
University of California Davis, Regional Burn Center
Sacramento, California, United States
Torrance Memorial
Torrance, California, United States
University of Florida Health
Gainesville, Florida, United States
University of Miami Health System
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Loyola Medicine
Maywood, Illinois, United States
University of Iowa Healthcare
Iowa City, Iowa, United States
University of Kansas Health System
Kansas City, Kansas, United States
Ascension Via Christi St. Francis
Wichita, Kansas, United States
Start Date
April 22, 2021
Primary Completion Date
August 1, 2025
Completion Date
September 1, 2025
Last Updated
February 1, 2024
400
ESTIMATED participants
Albumin Human
DRUG
Lead Sponsor
American Burn Association
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06559501