The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

January 31, 2024 updated by: American Burn Association

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
  • United States
    • Arizona
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis, Regional Burn Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • David G Greenhalgh, MD
      • Torrance, California, United States, 90505
        • Not yet recruiting
        • Torrance Memorial
        • Contact:
        • Principal Investigator:
          • Vimal Murthy, MD
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida Health
        • Contact:
        • Principal Investigator:
          • Ian Driscoll, MD
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami Health System
        • Contact:
        • Principal Investigator:
          • Shevonne Satahoo, MD
      • Tampa, Florida, United States, 33606
        • Not yet recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • David Smith, MD
    • Illinois
      • Maywood, Illinois, United States, 60153
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Healthcare
        • Principal Investigator:
          • Lucy Wibbenmeyer, MD
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Health System
        • Principal Investigator:
          • Dhaval Bhavsar, MD
        • Contact:
      • Wichita, Kansas, United States, 67214
        • Not yet recruiting
        • Ascension Via Christi St. Francis
        • Contact:
        • Principal Investigator:
          • Thomas Resch, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Jeremy Goverman, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Hennepin Healthcare
        • Principal Investigator:
          • Frederick Endorf, MD
        • Contact:
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • Cooperman Barnabas Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Marano, MD
    • New York
      • Buffalo, New York, United States, 14215
        • Recruiting
        • Erie County Medical Center
        • Contact:
        • Principal Investigator:
          • James Lukan, MD
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Westchester Medical Center Health Network
        • Contact:
        • Principal Investigator:
          • Francis Winski, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist Medical Center
        • Principal Investigator:
          • James Holmes, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey Claridge, MD
    • Oregon
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Legacy Health
        • Contact:
          • Kristin Hickey
        • Principal Investigator:
          • Niknam Eshraghi, MD, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Hospital
        • Contact:
        • Principal Investigator:
          • Ariel Aballay, MD
    • Tennessee
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Health
        • Principal Investigator:
          • Giavonni Lewis, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98014
        • Recruiting
        • Regional Burn Center at Harborview
        • Contact:
        • Principal Investigator:
          • Tam Pham
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Health
        • Contact:
        • Principal Investigator:
          • Angela Gibson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 or ejection fraction ≤ 35%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Crystalloid
Subjects in the crystalloid group will receive fluid resuscitation with Lactated Ringer's titrated each hour to achieve a urine output of 0.5-1mL/kg predicted body weight.
Active Comparator: Colloid
Subjects in the colloid group will receive fluid resuscitation with Lactated Ringer's and 5% human albumin solution introduced no earlier than 8 hours post burn and no later than 12 hours post burn in a ratio by volume of 1/3 albumin to 2/3 Lactated Ringer's, and titrated each hour to achieve a urine output of 0.5-1mL/kg (milliliter/kilogram) predicted body weight.
Drug: Albumin Human
Addition of albumin during acute resuscitation following burn injury
Other Names:
  • albumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of fluid received during resuscitation for burn injury
Time Frame: 24 hours post burn injury
Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn
24 hours post burn injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of fluid received during resuscitation for burn injury
Time Frame: 48 hours post burn injury
Total resuscitation volume at 48 hours in mL/kg/%TBSA burn.
48 hours post burn injury
Urine output during resuscitation for burn injury
Time Frame: 24 and 48 hours post burn injury
Mean hourly urine output during resuscitation for burn injury
24 and 48 hours post burn injury
Number of crossovers
Time Frame: 48 hours post burn injury
Number of crossovers between study arms during resuscitation for burn injury
48 hours post burn injury
Peak lactate and delta lactate
Time Frame: 48 hours post burn injury
peak lactate level and delta lactate (peak lactate minus admission lactate)
48 hours post burn injury
Peak intra-abdominal pressure (IAP) and delta IAP
Time Frame: 48 hours post burn injury
Peak intra-abdominal pressure (IAP) and delta IAP (peak IAP minus admission IAP)
48 hours post burn injury
Occurrence of Abdominal compartment syndrome
Time Frame: 48 hours post burn injury
Abdominal compartment syndrome during resuscitation for burn injury
48 hours post burn injury
Occurrence of Limb or abdominal fasciotomy
Time Frame: 48 hours post burn injury
Limb or abdominal fasciotomy during resuscitation for burn injury
48 hours post burn injury
Sequential Organ Failure Assessment (SOFA) score
Time Frame: 48, 72, and 96 hours post burn injury
Assessment of organ function or failure by Sequential Organ Failure Assessment (SOFA)score, with the higher score(s) indicating organ failure
48, 72, and 96 hours post burn injury
Acute kidney injury (AKI)
Time Frame: 96 hours post burn injury
Diagnosis of AKI
96 hours post burn injury
Duration of intubation/mechanical ventilation
Time Frame: 96 hours post burn injury
Duration of intubation/mechanical ventilation
96 hours post burn injury
PaO2/FiO2 ratios
Time Frame: 24, 48, 72, and 96 hours post burn injury
PaO2(partial pressure of oxygen)/FiO2(fraction of inspired oxygen inspired oxygen) ratios
24, 48, 72, and 96 hours post burn injury
Time to wound healing
Time Frame: 7 days post last surgery for grafting of burn injury
Time to wound healing defined as 7 days post last grafting surgery
7 days post last surgery for grafting of burn injury
Survival
Time Frame: 28 days post injury and hospital discharge
28 day survival and hospital stay survival
28 days post injury and hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Burn Association

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: David G Greenhalgh, MD, UC Davis Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2021

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1528946
  • CDMRP-JW180038 (Other Grant/Funding Number: US Army Department of Defense CDMRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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