The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

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: Completed
• Conditions: Burn Injury
• Intervention / Treatment: Drug: Albumin Human

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 (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, AB T6G 1Z1
      • University of Alberta
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Health Sciences Centre
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Arizona Burn Center Valleywise Health
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis, Regional Burn Center
    • Torrance, California, United States, 90505
      • Torrance Memorial
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida Health
    • Miami, Florida, United States, 33136
      • University of Miami Health System
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola Medicine
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Healthcare
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Health System
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi St. Francis
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Hennepin Healthcare
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Cooperman Barnabas Medical Center
  • New York
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center Health Network
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati College of Medicine
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
  • Oregon
    • Portland, Oregon, United States, 97227
      • Legacy Health
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • The University of Tennessee Health Science Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health
  • Washington
    • Seattle, Washington, United States, 98014
      • Regional Burn Center at Harborview
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Health

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Total resuscitation volume at 48 hours in mL/kg/%TBSA burn.	48 hours post burn injury
Urine output during resuscitation for burn injury	Mean hourly urine output during resuscitation for burn injury	24 and 48 hours post burn injury
Number of crossovers	Number of crossovers between study arms during resuscitation for burn injury	48 hours post burn injury
Peak lactate and delta lactate	peak lactate level and delta lactate (peak lactate minus admission lactate)	48 hours post burn injury
Peak intra-abdominal pressure (IAP) and delta IAP	Peak intra-abdominal pressure (IAP) and delta IAP (peak IAP minus admission IAP)	48 hours post burn injury
Occurrence of Abdominal compartment syndrome	Abdominal compartment syndrome during resuscitation for burn injury	48 hours post burn injury
Occurrence of Limb or abdominal fasciotomy	Limb or abdominal fasciotomy during resuscitation for burn injury	48 hours post 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	48, 72, and 96 hours post burn injury
Acute kidney injury (AKI)	Diagnosis of AKI	96 hours post burn injury
Duration of intubation/mechanical ventilation	Duration of intubation/mechanical ventilation	96 hours post burn injury
PaO2/FiO2 ratios	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 to wound healing defined as 7 days post last grafting surgery	7 days post last surgery for grafting of burn injury
Survival	28 day survival and hospital stay survival	28 days post injury and hospital discharge

Collaborators and Investigators

• Sponsor: American Burn Association
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: David G Greenhalgh, MD, UC Davis Health

Publications and helpful links

General Publications

• Pruitt BA Jr. Protection from excessive resuscitation: "pushing the pendulum back". J Trauma. 2000 Sep;49(3):567-8. doi: 10.1097/00005373-200009000-00030. No abstract available.
• Zak AL, Harrington DT, Barillo DJ, Lawlor DF, Shirani KZ, Goodwin CW. Acute respiratory failure that complicates the resuscitation of pediatric patients with scald injuries. J Burn Care Rehabil. 1999 Sep-Oct;20(5):391-9. doi: 10.1097/00004630-199909000-00011.
• 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.
• Klein MB, Hayden D, Elson C, Nathens AB, Gamelli RL, Gibran NS, Herndon DN, Arnoldo B, Silver G, Schoenfeld D, Tompkins RG. The association between fluid administration and outcome following major burn: a multicenter study. Ann Surg. 2007 Apr;245(4):622-8. doi: 10.1097/01.sla.0000252572.50684.49.
• Cartotto R, Callum J. A review of the use of human albumin in burn patients. J Burn Care Res. 2012 Nov-Dec;33(6):702-17. doi: 10.1097/BCR.0b013e31825b1cf6.
• Baxter CR, Shires T. Physiological response to crystalloid resuscitation of severe burns. Ann N Y Acad Sci. 1968 Aug 14;150(3):874-94. doi: 10.1111/j.1749-6632.1968.tb14738.x. No abstract available.
• Pruitt BA Jr. Fluid and electrolyte replacement in the burned patient. Surg Clin North Am. 1978 Dec;58(6):1291-1312. doi: 10.1016/s0039-6109(16)41692-0. No abstract available.
• Pruitt BA Jr. The burn patient: II. Later care and complications of thermal injury. Curr Probl Surg. 1979 May;16(5):1-95. doi: 10.1016/s0011-3840(79)80009-x.
• Cartotto RC, Innes M, Musgrave MA, Gomez M, Cooper AB. How well does the Parkland formula estimate actual fluid resuscitation volumes? J Burn Care Rehabil. 2002 Jul-Aug;23(4):258-65. doi: 10.1097/00004630-200207000-00006.
• Engrav LH, Colescott PL, Kemalyan N, Heimbach DM, Gibran NS, Solem LD, Dimick AR, Gamelli RL, Lentz CW. A biopsy of the use of the Baxter formula to resuscitate burns or do we do it like Charlie did it? J Burn Care Rehabil. 2000 Mar-Apr;21(2):91-5. doi: 10.1097/00004630-200021020-00002.
• Cancio LC, Chavez S, Alvarado-Ortega M, Barillo DJ, Walker SC, McManus AT, Goodwin CW. Predicting increased fluid requirements during the resuscitation of thermally injured patients. J Trauma. 2004 Feb;56(2):404-13; discussion 413-4. doi: 10.1097/01.TA.0000075341.43956.E4.
• Cartotto R, Zhou A. Fluid creep: the pendulum hasn't swung back yet! J Burn Care Res. 2010 Jul-Aug;31(4):551-8. doi: 10.1097/BCR.0b013e3181e4d732.
• Saffle JI. The phenomenon of "fluid creep" in acute burn resuscitation. J Burn Care Res. 2007 May-Jun;28(3):382-95. doi: 10.1097/BCR.0B013E318053D3A1.
• Recinos PR, Hartford CA, Ziffren SE. Fluid resuscitation of burn patients comparing a crystalloid with a colloid containing solution: a prospective study. J Iowa Med Soc. 1975 Oct;65(10):426-32. No abstract available.
• Jelenko C 3rd, Williams JB, Wheeler ML, Callaway BD, Fackler VK, Albers CA, Barger AA. Studies in shock and resuscitation, I: use of a hypertonic, albumin-containing, fluid demand regimen (HALFD) in resuscitation. Crit Care Med. 1979 Apr;7(4):157-67.
• Goodwin CW, Dorethy J, Lam V, Pruitt BA Jr. Randomized trial of efficacy of crystalloid and colloid resuscitation on hemodynamic response and lung water following thermal injury. Ann Surg. 1983 May;197(5):520-31. doi: 10.1097/00000658-198305000-00004.
• Cooper AB, Cohn SM, Zhang HS, Hanna K, Stewart TE, Slutsky AS; ALBUR Investigators. Five percent albumin for adult burn shock resuscitation: lack of effect on daily multiple organ dysfunction score. Transfusion. 2006 Jan;46(1):80-9. doi: 10.1111/j.1537-2995.2005.00667.x.
• Lawrence A, Faraklas I, Watkins H, Allen A, Cochran A, Morris S, Saffle J. Colloid administration normalizes resuscitation ratio and ameliorates "fluid creep". J Burn Care Res. 2010 Jan-Feb;31(1):40-7. doi: 10.1097/BCR.0b013e3181cb8c72.
• Faraklas I, Lam U, Cochran A, Stoddard G, Saffle J. Colloid normalizes resuscitation ratio in pediatric burns. J Burn Care Res. 2011 Jan-Feb;32(1):91-7. doi: 10.1097/BCR.0b013e318204b379.
• Asch MJ, Feldman RJ, Walker HL, Foley FD, Popp RL, Mason AD Jr, Pruitt BA Jr. Systemic and pulmonary hemodynamic changes accompanying thermal injury. Ann Surg. 1973 Aug;178(2):218-21. doi: 10.1097/00000658-197308000-00020. No abstract available.
• Demling RH, Kramer G, Harms B. Role of thermal injury-induced hypoproteinemia on fluid flux and protein permeability in burned and nonburned tissue. Surgery. 1984 Feb;95(2):136-44.
• Demling RH, Kramer GC, Gunther R, Nerlich M. Effect of nonprotein colloid on postburn edema formation in soft tissues and lung. Surgery. 1984 May;95(5):593-602.
• Onarheim H, Reed RK. Thermal skin injury: effect of fluid therapy on the transcapillary colloid osmotic gradient. J Surg Res. 1991 Mar;50(3):272-8. doi: 10.1016/0022-4804(91)90190-w.
• Moncrief JA. Effect of various fluid regimens and pharmacologic agents on the circulatory hemodynamics of the immediate postburn period. Ann Surg. 1966 Oct;164(4):723-52. doi: 10.1097/00000658-196610000-00017. No abstract available.
• Park SH, Hemmila MR, Wahl WL. Early albumin use improves mortality in difficult to resuscitate burn patients. J Trauma Acute Care Surg. 2012 Nov;73(5):1294-7. doi: 10.1097/TA.0b013e31827019b1.
• O'Mara MS, Slater H, Goldfarb IW, Caushaj PF. A prospective, randomized evaluation of intra-abdominal pressures with crystalloid and colloid resuscitation in burn patients. J Trauma. 2005 May;58(5):1011-8. doi: 10.1097/01.ta.0000162732.39083.15.
• Muller Dittrich MH, Brunow de Carvalho W, Lopes Lavado E. Evaluation of the "Early" Use of Albumin in Children with Extensive Burns: A Randomized Controlled Trial. Pediatr Crit Care Med. 2016 Jun;17(6):e280-6. doi: 10.1097/PCC.0000000000000728.
• Mehrkens HH, Ahnefeld FW. Volume and fluid replacement in the early post burn period: an animal experimental study. Burns 1979;5:113-15
• Greenhalgh DG. Current Thoughts on Burn Resuscitation. Adv Surg. 2024 Sep;58(1):1-17. doi: 10.1016/j.yasu.2024.04.001. Epub 2024 May 8.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): September 29, 2025
• Study Completion (Actual): September 29, 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 (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Resuscitation
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Amino Acids, Peptides, and Proteins; Proteins; Blood Proteins; Serum Albumin; Albumins; Serum Albumin, Human
• 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