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The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

Primary Purpose

Burn Injury

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Albumin Human
Sponsored by
American Burn Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Injury focused on measuring Resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%)

Sites / Locations

  • Arizona Burn Center Valleywise HealthRecruiting
  • University of California Davis, Regional Burn CenterRecruiting
  • Torrance Memorial
  • University of Florida HealthRecruiting
  • University of Miami Health System
  • University of South Florida
  • Loyola Medicine
  • University of Iowa HealthcareRecruiting
  • University of Kansas Health SystemRecruiting
  • Ascension Via Christi St. Francis
  • Massachusetts General HospitalRecruiting
  • Hennepin HealthcareRecruiting
  • Cooperman Barnabas Medical CenterRecruiting
  • Erie County Medical CenterRecruiting
  • Westchester Medical Center Health NetworkRecruiting
  • Atrium Health Wake Forest Baptist Medical CenterRecruiting
  • University of Cincinnati College of MedicineRecruiting
  • Metrohealth Medical CenterRecruiting
  • Legacy HealthRecruiting
  • West Penn HospitalRecruiting
  • The University of Tennessee Health Science CenterRecruiting
  • University of Utah HealthRecruiting
  • Regional Burn Center at HarborviewRecruiting
  • University of Wisconsin HealthRecruiting
  • University of Alberta
  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Crystalloid

Colloid

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Volume of fluid received during resuscitation for burn injury
Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn

Secondary Outcome Measures

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

Full Information

First Posted
April 16, 2020
Last Updated
August 9, 2022
Sponsor
American Burn Association
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04356859
Brief Title
The Acute Burn ResUscitation Multicenter Prospective Trial
Acronym
ABRUPT2
Official Title
The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Burn Association
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury
Keywords
Resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization will be based on "intent to treat." Consecutively admitted and eligible burn patients will be assigned to one of two treatment groups (Colloid or Crystalloid) within 12 hours of burn injury.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crystalloid
Arm Type
No Intervention
Arm Description
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.
Arm Title
Colloid
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Albumin Human
Other Intervention Name(s)
albumin
Intervention Description
Addition of albumin during acute resuscitation following burn injury
Primary Outcome Measure Information:
Title
Volume of fluid received during resuscitation for burn injury
Description
Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn
Time Frame
24 hours post burn injury
Secondary Outcome Measure Information:
Title
Volume of fluid received during resuscitation for burn injury
Description
Total resuscitation volume at 48 hours in mL/kg/%TBSA burn.
Time Frame
48 hours post burn injury
Title
Urine output during resuscitation for burn injury
Description
Mean hourly urine output during resuscitation for burn injury
Time Frame
24 and 48 hours post burn injury
Title
Number of crossovers
Description
Number of crossovers between study arms during resuscitation for burn injury
Time Frame
48 hours post burn injury
Title
Peak lactate and delta lactate
Description
peak lactate level and delta lactate (peak lactate minus admission lactate)
Time Frame
48 hours post burn injury
Title
Peak intra-abdominal pressure (IAP) and delta IAP
Description
Peak intra-abdominal pressure (IAP) and delta IAP (peak IAP minus admission IAP)
Time Frame
48 hours post burn injury
Title
Occurrence of Abdominal compartment syndrome
Description
Abdominal compartment syndrome during resuscitation for burn injury
Time Frame
48 hours post burn injury
Title
Occurrence of Limb or abdominal fasciotomy
Description
Limb or abdominal fasciotomy during resuscitation for burn injury
Time Frame
48 hours post burn injury
Title
Sequential Organ Failure Assessment (SOFA) score
Description
Assessment of organ function or failure by Sequential Organ Failure Assessment (SOFA)score, with the higher score(s) indicating organ failure
Time Frame
48, 72, and 96 hours post burn injury
Title
Acute kidney injury (AKI)
Description
Diagnosis of AKI
Time Frame
96 hours post burn injury
Title
Duration of intubation/mechanical ventilation
Description
Duration of intubation/mechanical ventilation
Time Frame
96 hours post burn injury
Title
PaO2/FiO2 ratios
Description
PaO2(partial pressure of oxygen)/FiO2(fraction of inspired oxygen inspired oxygen) ratios
Time Frame
24, 48, 72, and 96 hours post burn injury
Title
Time to wound healing
Description
Time to wound healing defined as 7 days post last grafting surgery
Time Frame
7 days post last surgery for grafting of burn injury
Title
Survival
Description
28 day survival and hospital stay survival
Time Frame
28 days post injury and hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katrina Falwell, RN, BSN
Phone
916-453-2134
Email
kafalwell@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Beth Lawless, RN, MS
Phone
916-453-2132
Email
mblawless@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Greenhalgh, MD
Organizational Affiliation
UC Davis Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Burn Center Valleywise Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Islas
Email
claudia.islas@valleywise.health.org
First Name & Middle Initial & Last Name & Degree
Karen Richey
Email
karen.richey2@valleywisehealth.org
First Name & Middle Initial & Last Name & Degree
Kevin Foster, MD
Facility Name
University of California Davis, Regional Burn Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Falwell, RN, BSN
Phone
916-453-2134
Email
kafalwell@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
MaryBeth Lawless, RN, MS
Phone
916-453-2132
Email
mblawless@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
David G Greenhalgh, MD
Facility Name
Torrance Memorial
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naiwei Hsu-Chang
Email
Naiwei.chang@tmmc.com
First Name & Middle Initial & Last Name & Degree
Vimal Murthy, MD
Facility Name
University of Florida Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tera Thigpin
Email
tera.thigpin@surgery.ufl.edu
First Name & Middle Initial & Last Name & Degree
Ian Driscoll, MD
Facility Name
University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ron Manning
Email
rmanning@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Shevonne Satahoo, MD
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thanh Tran
Email
thanhtran@health.usf.edu
First Name & Middle Initial & Last Name & Degree
David Smith, MD
Facility Name
Loyola Medicine
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aerial Williams
Email
awilliams23@luc.edu
First Name & Middle Initial & Last Name & Degree
Crystal Wiley-Brown
Email
cwileybrown@luc.edu
First Name & Middle Initial & Last Name & Degree
John Kubasiak, MD
Facility Name
University of Iowa Healthcare
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Collette Galet
Email
colette-galet@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Lucy Wibbenmeyer, MD
Facility Name
University of Kansas Health System
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Reynolds
Email
jreynolds11@kumc.edu
First Name & Middle Initial & Last Name & Degree
Dhaval Bhavsar, MD
Facility Name
Ascension Via Christi St. Francis
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Fischer
Email
sarah.fischer@ascension.org
First Name & Middle Initial & Last Name & Degree
Thomas Resch, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenic Annand
Email
dannand@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jeremy Goverman, MD
Facility Name
Hennepin Healthcare
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Colonna
Email
emily.colonna@hcmed.org
First Name & Middle Initial & Last Name & Degree
Frederick Endorf, MD
Facility Name
Cooperman Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Alem
Email
paula.alem@rwjbh.org
First Name & Middle Initial & Last Name & Degree
Michael Marano, MD
Facility Name
Erie County Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcy Jordan
Email
marcyjor@buffalo.edu
First Name & Middle Initial & Last Name & Degree
James Lukan, MD
Facility Name
Westchester Medical Center Health Network
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anuritha Tirumani
Email
anuritha.tirumani@wmchealth.org
First Name & Middle Initial & Last Name & Degree
Francis Winski, MD
Facility Name
Atrium Health Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D'Ann Hershel
Email
dhershel@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
James Holmes, MD
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Rodriguez
Email
rodrigc@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Dina Gomaa
Email
gomaada@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Dale, MD
Facility Name
Metrohealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Newman
Email
cnewman@metrohealth.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Claridge, MD
Facility Name
Legacy Health
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Hickey
First Name & Middle Initial & Last Name & Degree
Niknam Eshraghi, MD, MD
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelly Evans
Email
shelly.evans@ahn.org
First Name & Middle Initial & Last Name & Degree
Ariel Aballay, MD
Facility Name
The University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Shaw
Email
dmhill@regionalonehealth.org; yshaw@uthsc.edu
First Name & Middle Initial & Last Name & Degree
Ram Velamuri, MD
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhai
Email
yan.zhai@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Giavonni Lewis, MD
Facility Name
Regional Burn Center at Harborview
City
Seattle
State/Province
Washington
ZIP/Postal Code
98014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Eschelbach
Email
eschee13@uw.edu
First Name & Middle Initial & Last Name & Degree
Tam Pham
Facility Name
University of Wisconsin Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Wang
Email
wangm@surgery.wisc.edu
First Name & Middle Initial & Last Name & Degree
Angela Gibson, MD
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
AB T6G 1Z1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharada Manchikanti
Email
sharada.manchikanti@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Peter Kwan, MD
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Calvieri
Email
Elizabeth.Calvieri@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Robert Cartotto, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
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Hobson KG, Young KM, Ciraulo A, Palmieri TL, Greenhalgh DG. Release of abdominal compartment syndrome improves survival in patients with burn injury. J Trauma. 2002 Dec;53(6):1129-33; discussion 1133-4. doi: 10.1097/00005373-200212000-00016.
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