The Acute Burn Resuscitation Multicenter Prospective Observational Trial

Burns Clinical Trial

— ABRUPT  

Official title:

The Acute Burn Resuscitation Multicenter Prospective Observational Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144427
• Other study ID #: ABuRN-001
• Secondary ID: W81XWH-16-2-0048
• Status: Completed
• Start date: February 24, 2017
• Est. completion date: July 15, 2021

Study information

• Verified date: July 2021
• Source: American Burn Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, non-interventional, observational study of consecutive burn patients admitted to 20 selected burn centers in North America. Primarily, data collection will be continuous "real-time" documentation of fluid infusion rates, vital signs and laboratory values of patients receiving fluid resuscitation during the first 48 hours following burn injury. All aspects of the resuscitation and all investigations performed will be according to the participating center's regular protocol, as this is purely an observational and non-interventional study. Further data collection on outcomes (organ function, ventilation duration, length of stay, and survival) will be collected at 72h, 96 h, and at hospital discharge.

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:

1. Subjects that received crystalloids only compared to subjects that received crystalloids plus albumin.

2. 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).

3. Characteristics of resuscitation prior to the start of albumin ("pre-albumin") compared to characteristics of resuscitation following initiation of albumin ("post albumin").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Shock

Locations

Country	Name	City	State
United States	University of California Davis Medical Center-Regional Burn Center	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
American Burn Association	U.S. Army Medical Research Acquisition Activity, University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (31)

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. — View Citation

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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. Review. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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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

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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. — View Citation

Pruitt BA Jr. Protection from excessive resuscitation: "pushing the pendulum back". J Trauma. 2000 Sep;49(3):567-8. — 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. Review. — View Citation

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. — View Citation

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid resuscitation volume	Total fluid resuscitation volume in mL/kg/% TBSA (total body surface area) burn	24 hours post burn injury
Primary	albumin : crystalloid ratio	albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)	24 hours hours post burn injury
Primary	Fluid resuscitation volume	Total fluid resuscitation volume in mL/kg/% TBSA burn	48 hours post burn injury
Primary	albumin : crystalloid ratio	albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)	48 hours post burn injury
Secondary	I/O Ratio	Total intake and output ratio	24 hours post burn injury
Secondary	I/O Ratio	Total intake and output ratio	48 hours post burn injury
Secondary	Doses of vasopressors and inotropes	Total doses of vasopressors and inotropes	24 hours post burn injury
Secondary	Doses of vasopressors and inotropes	Total doses of vasopressors and inotropes	48 hours post burn injury
Secondary	Fasciotomy	Documentation of fasciotomy performed	during the first 48 hours post burn injury
Secondary	abdominal compartment syndrome	Occurrence of abdominal compartment syndrome	during the first 48 hours post burn injury
Secondary	completion of resuscitation	Time to completion of resuscitation	up to 48 hours post burn injury
Secondary	AKIN Score (acute kidney injury network)	Acute Kidney Injury Network stage	24 hours post burn injury
Secondary	AKIN Score	Acute Kidney Injury Network stage	48 hours post burn injury
Secondary	AKIN Score	Acute Kidney Injury Network stage	72 hours post burn injury
Secondary	AKIN Score	Acute Kidney Injury Network stage	96 hours post burn injury
Secondary	SOFA score (sequential organ failure assessment)	Sequential Organ Failure Assessment	24 hours post burn injury
Secondary	SOFA score	Sequential Organ Failure Assessment	48 hours post burn injury
Secondary	SOFA score	Sequential Organ Failure Assessment	72 hours post burn injury
Secondary	SOFA score	Sequential Organ Failure Assessment	96 hours post burn injury
Secondary	Mechanical Ventilation	Duration of mechanical ventilation and ventilator free days	from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
Secondary	Hospital Stay	Length of hospital stay	from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
Secondary	Survival	In hospital and 28 day survival	28 days post burn injury or death, whichever occurs first