- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03144427
The Acute Burn Resuscitation Multicenter Prospective Observational Trial (ABRUPT)
Study Overview
Detailed Description
This is a prospective observational study with no intervention. Study sites have been selected to include wide cross-representation of resuscitation practices using crystalloids alone, crystalloid plus albumin, and among sites that use albumin, variable approaches to the timing of albumin initiation.
Detailed data will be continuously collected in "real time" during fluid resuscitation over the 1st 48 hours following a burn injury. Data collection during this phase will be done prospectively, hour-by-hour, by the bedside nurse caring for the patient. Primarily this data collection will involve recording of resuscitation fluid volumes, urinary output, vital signs (heart rate and blood pressure), and use of vasopressors and inotropes. Outcome data (organ function, need for mechanical ventilation, hospital length of stay, and survival) will be collected at various time points during the subjects' acute care stay.
At completion of the study we intend to make the following comparisons:
- Subjects that received crystalloids only compared to subjects that received crystalloids plus albumin.
- Subjects that had albumin started "early" (< 8 hours post burn), compared to subjects that had albumin started "intermediate" (8-12 hours post burn), compared to subjects that had albumin started "late" (>12 hours post burn).
- Characteristics of resuscitation prior to the start of albumin ("pre-albumin") compared to characteristics of resuscitation following initiation of albumin ("post albumin").
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
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Sacramento, California, United States, 95817
- University of California Davis Medical Center-Regional Burn Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- ≥ 20% TBSA burns
- Admitted to the burn center ≤ 12 post injury
Exclusion Criteria:
- Significant associated trauma
- High voltage (≥ 1000 volts) electrical burns
- Surgery anticipated within 48 hours from injury
- Fresh frozen plasma (FFP) anticipated to be given at any time ≤ 48 hours from injury
- Hypertonic saline (HTS) anticipated to be given at any time ≤ 48 hours from injury
- Hydroxyethyl starch (HES) anticipated to be given at any time ≤ 48 hours from injury
- High dose Vitamin C infusion is anticipated to be given at any time ≤ 48 hours from injury
- Death occurs or comfort measures are instituted within ≤ 48 hours from injury
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Burns
Patients with burns to 20% or more of their BSA (body surface area) require resuscitation with intravenous crystalloid fluids in order to avoid organ failure and death
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fluid resuscitation volume
Time Frame: 24 hours post burn injury
|
Total fluid resuscitation volume in mL/kg/% TBSA (total body surface area) burn
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24 hours post burn injury
|
albumin : crystalloid ratio
Time Frame: 24 hours hours post burn injury
|
albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)
|
24 hours hours post burn injury
|
Fluid resuscitation volume
Time Frame: 48 hours post burn injury
|
Total fluid resuscitation volume in mL/kg/% TBSA burn
|
48 hours post burn injury
|
albumin : crystalloid ratio
Time Frame: 48 hours post burn injury
|
albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)
|
48 hours post burn injury
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
I/O Ratio
Time Frame: 24 hours post burn injury
|
Total intake and output ratio
|
24 hours post burn injury
|
I/O Ratio
Time Frame: 48 hours post burn injury
|
Total intake and output ratio
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48 hours post burn injury
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Doses of vasopressors and inotropes
Time Frame: 24 hours post burn injury
|
Total doses of vasopressors and inotropes
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24 hours post burn injury
|
Doses of vasopressors and inotropes
Time Frame: 48 hours post burn injury
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Total doses of vasopressors and inotropes
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48 hours post burn injury
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Fasciotomy
Time Frame: during the first 48 hours post burn injury
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Documentation of fasciotomy performed
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during the first 48 hours post burn injury
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abdominal compartment syndrome
Time Frame: during the first 48 hours post burn injury
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Occurrence of abdominal compartment syndrome
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during the first 48 hours post burn injury
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completion of resuscitation
Time Frame: up to 48 hours post burn injury
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Time to completion of resuscitation
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up to 48 hours post burn injury
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AKIN Score (acute kidney injury network)
Time Frame: 24 hours post burn injury
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Acute Kidney Injury Network stage
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24 hours post burn injury
|
AKIN Score
Time Frame: 48 hours post burn injury
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Acute Kidney Injury Network stage
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48 hours post burn injury
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AKIN Score
Time Frame: 72 hours post burn injury
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Acute Kidney Injury Network stage
|
72 hours post burn injury
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AKIN Score
Time Frame: 96 hours post burn injury
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Acute Kidney Injury Network stage
|
96 hours post burn injury
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SOFA score (sequential organ failure assessment)
Time Frame: 24 hours post burn injury
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Sequential Organ Failure Assessment
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24 hours post burn injury
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SOFA score
Time Frame: 48 hours post burn injury
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Sequential Organ Failure Assessment
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48 hours post burn injury
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SOFA score
Time Frame: 72 hours post burn injury
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Sequential Organ Failure Assessment
|
72 hours post burn injury
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SOFA score
Time Frame: 96 hours post burn injury
|
Sequential Organ Failure Assessment
|
96 hours post burn injury
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Mechanical Ventilation
Time Frame: from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
|
Duration of mechanical ventilation and ventilator free days
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from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
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Hospital Stay
Time Frame: from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
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Length of hospital stay
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from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
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Survival
Time Frame: 28 days post burn injury or death, whichever occurs first
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In hospital and 28 day survival
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28 days post burn injury or death, whichever occurs first
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Greenhalgh, MD, University of California, Davis
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.
- Holcomb JB, del Junco DJ, Fox EE, Wade CE, Cohen MJ, Schreiber MA, Alarcon LH, Bai Y, Brasel KJ, Bulger EM, Cotton BA, Matijevic N, Muskat P, Myers JG, Phelan HA, White CE, Zhang J, Rahbar MH; PROMMTT Study Group. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013 Feb;148(2):127-36. doi: 10.1001/2013.jamasurg.387.
- Holcomb JB, Fox EE, Wade CE; PROMMTT Study Group. The PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study. J Trauma Acute Care Surg. 2013 Jul;75(1 Suppl 1):S1-2. doi: 10.1097/TA.0b013e3182983876. No abstract available.
- Rahbar MH, Fox EE, del Junco DJ, Cotton BA, Podbielski JM, Matijevic N, Cohen MJ, Schreiber MA, Zhang J, Mirhaji P, Duran SJ, Reynolds RJ, Benjamin-Garner R, Holcomb JB; PROMMTT Investigators. Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study. Resuscitation. 2012 Apr;83(4):459-64. doi: 10.1016/j.resuscitation.2011.09.019. Epub 2011 Oct 12.
- Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
- 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.
- Baxter CR, Marvin J, Curreri PW. Fluid and electrolyte therapy of burn shock. Heart Lung. 1973 Sep-Oct;2(5):707-13. 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.
- 25. 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABuRN-001
- W81XWH-16-2-0048 Log#MB150076 (Other Grant/Funding Number: U.S. Army Medical Research Acquisition Activity)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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