The Acute Burn ResUscitation Multicenter Prospective Trial

Last updated: May 18, 2026
Sponsor: American Burn Association
Overall Status: Completed

Phase

N/A

Condition

Skin Wounds

Hyponatremia

Treatment

Albumin Human

Clinical Study ID

NCT04356859
1528946
CDMRP-JW180038
  • Ages > 18
  • All Genders

Study 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 acute burn involving at least 25% of their total body surface area.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 orejection fraction ≤ 35%)

Study Design

Total Participants: 101
Treatment Group(s): 1
Primary Treatment: Albumin Human
Phase:
Study Start date:
April 22, 2021
Estimated Completion Date:
September 29, 2025

Study 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 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.

Connect with a study center

  • University of Alberta

    Edmonton, Alberta AB T6G 1Z1
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N3M5
    Canada

    Site Not Available

  • Arizona Burn Center Valleywise Health

    Phoenix, Arizona 85008
    United States

    Site Not Available

  • University of California Davis, Regional Burn Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Torrance Memorial

    Torrance, California 90505
    United States

    Site Not Available

  • University of Florida Health

    Gainesville, Florida 32608
    United States

    Site Not Available

  • University of Miami Health System

    Miami, Florida 33136
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Loyola Medicine

    Maywood, Illinois 60153
    United States

    Site Not Available

  • University of Iowa Healthcare

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kansas Health System

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Ascension Via Christi St. Francis

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Hennepin Healthcare

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Erie County Medical Center

    Buffalo, New York 14215
    United States

    Site Not Available

  • Westchester Medical Center Health Network

    Valhalla, New York 10595
    United States

    Site Not Available

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Metrohealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Legacy Health

    Portland, Oregon 97227
    United States

    Site Not Available

  • West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • The University of Tennessee Health Science Center

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • University of Utah Health

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Regional Burn Center at Harborview

    Seattle, Washington 98014
    United States

    Site Not Available

  • University of Wisconsin Health

    Madison, Wisconsin 53792
    United States

    Site Not Available

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