Clinical trial NCT03144427: The Acute Burn Resuscitation Multicenter Prospective Observational Trial
Official title: The Acute Burn Resuscitation Multicenter Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Shock
Keywords: albumin
resuscitation
burns
shock
fluid creep
Lead sponsor: American Burn Association
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research Acquisition Activity
name: University of California, Davis
First posted: 2017-05-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients must be ≥ 18 years of age with a TBSA burn of ≥ 20%, and they must have been admitted to the burn center ≤ 12 hours following the injury.

Brief 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.

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:

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").

Eligibility criteria: 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

Primary outcomes:
measure: Fluid resuscitation volume
timeFrame: 24 hours post burn injury
measure: albumin : crystalloid ratio
timeFrame: 24 hours hours post burn injury
measure: Fluid resuscitation volume
timeFrame: 48 hours post burn injury
measure: albumin : crystalloid ratio
timeFrame: 48 hours post burn injury
Secondary outcomes:
measure: I/O Ratio
timeFrame: 24 hours post burn injury
measure: I/O Ratio
timeFrame: 48 hours post burn injury
measure: Doses of vasopressors and inotropes
timeFrame: 24 hours post burn injury
measure: Doses of vasopressors and inotropes
timeFrame: 48 hours post burn injury
measure: Fasciotomy
timeFrame: during the first 48 hours post burn injury
measure: abdominal compartment syndrome
timeFrame: during the first 48 hours post burn injury
measure: completion of resuscitation
timeFrame: up to 48 hours post burn injury
measure: AKIN Score (acute kidney injury network)
timeFrame: 24 hours post burn injury
measure: AKIN Score
timeFrame: 48 hours post burn injury
measure: AKIN Score
timeFrame: 72 hours post burn injury
measure: AKIN Score
timeFrame: 96 hours post burn injury
measure: SOFA score (sequential organ failure assessment)
timeFrame: 24 hours post burn injury
measure: SOFA score
timeFrame: 48 hours post burn injury
measure: SOFA score
timeFrame: 72 hours post burn injury
measure: SOFA score
timeFrame: 96 hours post burn injury
measure: Mechanical Ventilation
timeFrame: from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
measure: Hospital Stay
timeFrame: from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
measure: Survival
timeFrame: 28 days post burn injury or death, whichever occurs first
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center-Regional Burn Center
state: California
Study officials:
affiliation: University of California, Davis
name: David Greenhalgh, MD
role: PRINCIPAL_INVESTIGATOR
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