The Acute Burn ResUscitation Multicenter Prospective Trial

Burn Injury Clinical Trial

— ABRUPT2  

Official title:

The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04356859
• Other study ID #: 1528946
• Secondary ID: CDMRP-JW180038
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: American Burn Association
• Contact: Katrina Falwell, RN, BSN
• Phone: 916-453-2134
• Email: kafalwell[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Burn Injury
• Burns

Intervention

Drug:
• Albumin Human
Addition of albumin during acute resuscitation following burn injury

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Erie County Medical Center	Buffalo	New York
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Metrohealth Medical Center	Cleveland	Ohio
United States	University of Florida Health	Gainesville	Florida
United States	University of Iowa Healthcare	Iowa City	Iowa
United States	University of Kansas Health System	Kansas City	Kansas
United States	Cooperman Barnabas Medical Center	Livingston	New Jersey
United States	University of Wisconsin Health	Madison	Wisconsin
United States	Loyola Medicine	Maywood	Illinois
United States	The University of Tennessee Health Science Center	Memphis	Tennessee
United States	University of Miami Health System	Miami	Florida
United States	Hennepin Healthcare	Minneapolis	Minnesota
United States	Arizona Burn Center Valleywise Health	Phoenix	Arizona
United States	West Penn Hospital	Pittsburgh	Pennsylvania
United States	Legacy Health	Portland	Oregon
United States	University of California Davis, Regional Burn Center	Sacramento	California
United States	University of Utah Health	Salt Lake City	Utah
United States	Regional Burn Center at Harborview	Seattle	Washington
United States	University of South Florida	Tampa	Florida
United States	Torrance Memorial	Torrance	California
United States	Westchester Medical Center Health Network	Valhalla	New York
United States	Ascension Via Christi St. Francis	Wichita	Kansas
United States	Atrium Health Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
American Burn Association	United States Department of Defense

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (28)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Mehrkens HH, Ahnefeld FW. Volume and fluid replacement in the early post burn period: an animal experimental study. Burns 1979;5:113-15

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Urine output during resuscitation for burn injury	Mean hourly urine output during resuscitation for burn injury	24 and 48 hours post burn injury
Secondary	Number of crossovers	Number of crossovers between study arms during resuscitation for burn injury	48 hours post burn injury
Secondary	Peak lactate and delta lactate	peak lactate level and delta lactate (peak lactate minus admission lactate)	48 hours post burn injury
Secondary	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
Secondary	Occurrence of Abdominal compartment syndrome	Abdominal compartment syndrome during resuscitation for burn injury	48 hours post burn injury
Secondary	Occurrence of Limb or abdominal fasciotomy	Limb or abdominal fasciotomy during resuscitation for burn injury	48 hours post burn injury
Secondary	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
Secondary	Acute kidney injury (AKI)	Diagnosis of AKI	96 hours post burn injury
Secondary	Duration of intubation/mechanical ventilation	Duration of intubation/mechanical ventilation	96 hours post burn injury
Secondary	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
Secondary	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
Secondary	Survival	28 day survival and hospital stay survival	28 days post injury and hospital discharge