The Acute Burn Resuscitation Multicenter Prospective Observational Trial

NCT ID: NCT03144427

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-24
• Study Completion Date: 2021-07-15

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").

Conditions

Burns; Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research Acquisition Activity

FED

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

American Burn Association

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Greenhalgh, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis Medical Center-Regional Burn Center

Sacramento, California, United States

Countries

United States

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Other Identifiers

W81XWH-16-2-0048 Log#MB150076

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ABuRN-001

Identifier Type: -

Identifier Source: org_study_id