The Acute Burn ResUscitation Multicenter Prospective Trial

NCT04356859 | Unknown

• 2 other identifiers: 1528946CDMRP-JW180038
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 26

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.

Conditions

Burn Injury

Keywords

Resuscitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Volume of fluid received during resuscitation for burn injury

  48 hours post burn injury

• Urine output during resuscitation for burn injury

  24 and 48 hours post burn injury

• Number of crossovers

  48 hours post burn injury

• Peak lactate and delta lactate

  48 hours post burn injury

• Peak intra-abdominal pressure (IAP) and delta IAP

  48 hours post burn injury

Study Arms (2)

Crystalloid

NO INTERVENTION

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.

Colloid

ACTIVE COMPARATOR

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

Interventions

Albumin Human DRUG

Addition of albumin during acute resuscitation following burn injury

Also known as: albumin

Colloid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%)

Sponsors & Collaborators

• American Burn Association: lead
• United States Department of Defense: collaborator

Study Sites (26)

Arizona Burn Center Valleywise Health

Phoenix, Arizona, 85008, United States

RECRUITING

University of California Davis, Regional Burn Center

Sacramento, California, 95817, United States

RECRUITING

Torrance Memorial

Torrance, California, 90505, United States

NOT YET RECRUITING

University of Florida Health

Gainesville, Florida, 32608, United States

RECRUITING

University of Miami Health System

Miami, Florida, 33136, United States

NOT YET RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

NOT YET RECRUITING

Loyola Medicine

Maywood, Illinois, 60153, United States

NOT YET RECRUITING

University of Iowa Healthcare

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Health System

Kansas City, Kansas, 66160, United States

RECRUITING

Ascension Via Christi St. Francis

Wichita, Kansas, 67214, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Hennepin Healthcare

Minneapolis, Minnesota, 55404, United States

RECRUITING

Cooperman Barnabas Medical Center

Livingston, New Jersey, 07039, United States

RECRUITING

Erie County Medical Center

Buffalo, New York, 14215, United States

RECRUITING

Westchester Medical Center Health Network

Valhalla, New York, 10595, United States

RECRUITING

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

RECRUITING

Metrohealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

Legacy Health

Portland, Oregon, 97227, United States

RECRUITING

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

The University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

RECRUITING

University of Utah Health

Salt Lake City, Utah, 84132, United States

RECRUITING

Regional Burn Center at Harborview

Seattle, Washington, 98014, United States

RECRUITING

University of Wisconsin Health

Madison, Wisconsin, 53792, United States

RECRUITING

University of Alberta

Edmonton, Alberta, AB T6G 1Z1, Canada

NOT YET RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

Related Publications (28)

• 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.

  PMID: 11003341 BACKGROUND

• 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.

  PMID: 10501327 BACKGROUND

• 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.

  PMID: 12478039 BACKGROUND

• 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.

  PMID: 17414612 BACKGROUND

• 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.

  PMID: 1194720 BACKGROUND

• 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.

  PMID: 6342554 BACKGROUND

• 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.

  PMID: 16398734 BACKGROUND

• 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.

  PMID: 15920417 BACKGROUND

• 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.

  PMID: 27077832 BACKGROUND

• 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.

  PMID: 23143614 BACKGROUND

• 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.

  PMID: 4973463 BACKGROUND

• 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.

  PMID: 734610 BACKGROUND

• 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.

  PMID: 376227 BACKGROUND

• 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.

  PMID: 12142578 BACKGROUND

• 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.

  PMID: 20616649 BACKGROUND

• 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.

  PMID: 10752739 BACKGROUND

• 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.

  PMID: 14960986 BACKGROUND

• 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.

  PMID: 17438489 BACKGROUND

• 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.

  PMID: 446052 BACKGROUND

• 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.

  PMID: 20061836 BACKGROUND

• 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.

  PMID: 21131844 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 4723430 BACKGROUND

• 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.

  PMID: 6695330 BACKGROUND

• 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.

  PMID: 6200946 BACKGROUND

• 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.

  PMID: 1999916 BACKGROUND

• 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.

  PMID: 5924792 BACKGROUND

• 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.

  PMID: 23117385 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Serum Albumin, Human; Albumins

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Serum Albumin; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• David G Greenhalgh, MD

  UC Davis Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrina Falwell, RN, BSN

CONTACT

916-453-2134; kafalwell@ucdavis.edu

Mary Beth Lawless, RN, MS

CONTACT

916-453-2132; mblawless@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 22, 2020
• Study Start: April 22, 2021
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (24)