The Acute Burn ResUscitation Multicenter Prospective Trial
NCT ID: NCT04356859
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2021-04-22
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
Albumin Human
Addition of albumin during acute resuscitation following burn injury
Interventions
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Albumin Human
Addition of albumin during acute resuscitation following burn injury
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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%)
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
American Burn Association
OTHER
Responsible Party
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Principal Investigators
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David G Greenhalgh, MD
Role: PRINCIPAL_INVESTIGATOR
UC Davis Health
Locations
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Arizona Burn Center Valleywise Health
Phoenix, Arizona, United States
University of California Davis, Regional Burn Center
Sacramento, California, United States
Torrance Memorial
Torrance, California, United States
University of Florida Health
Gainesville, Florida, United States
University of Miami Health System
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Loyola Medicine
Maywood, Illinois, United States
University of Iowa Healthcare
Iowa City, Iowa, United States
University of Kansas Health System
Kansas City, Kansas, United States
Ascension Via Christi St. Francis
Wichita, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Hennepin Healthcare
Minneapolis, Minnesota, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
Erie County Medical Center
Buffalo, New York, United States
Westchester Medical Center Health Network
Valhalla, New York, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
Legacy Health
Portland, Oregon, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
The University of Tennessee Health Science Center
Memphis, Tennessee, United States
University of Utah Health
Salt Lake City, Utah, United States
Regional Burn Center at Harborview
Seattle, Washington, United States
University of Wisconsin Health
Madison, Wisconsin, United States
University of Alberta
Edmonton, Alberta, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Kristin Hickey
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Mehrkens HH, Ahnefeld FW. Volume and fluid replacement in the early post burn period: an animal experimental study. Burns 1979;5:113-15
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.
Other Identifiers
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CDMRP-JW180038
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1528946
Identifier Type: -
Identifier Source: org_study_id
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