The Acute Burn Resuscitation Multicenter Prospective Observational Trial

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2020

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").

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Fluid resuscitation volume
    • Time Frame: 24 hours post burn injury
    • Total fluid resuscitation volume in mL/kg/% TBSA (total body surface area) burn
  • albumin : crystalloid ratio
    • Time Frame: 24 hours hours post burn injury
    • albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)
  • Fluid resuscitation volume
    • Time Frame: 48 hours post burn injury
    • Total fluid resuscitation volume in mL/kg/% TBSA burn
  • albumin : crystalloid ratio
    • Time Frame: 48 hours post burn injury
    • albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)

Secondary Measures

  • I/O Ratio
    • Time Frame: 24 hours post burn injury
    • Total intake and output ratio
  • I/O Ratio
    • Time Frame: 48 hours post burn injury
    • Total intake and output ratio
  • Doses of vasopressors and inotropes
    • Time Frame: 24 hours post burn injury
    • Total doses of vasopressors and inotropes
  • Doses of vasopressors and inotropes
    • Time Frame: 48 hours post burn injury
    • Total doses of vasopressors and inotropes
  • Fasciotomy
    • Time Frame: during the first 48 hours post burn injury
    • Documentation of fasciotomy performed
  • abdominal compartment syndrome
    • Time Frame: during the first 48 hours post burn injury
    • Occurrence of abdominal compartment syndrome
  • completion of resuscitation
    • Time Frame: up to 48 hours post burn injury
    • Time to completion of resuscitation
  • AKIN Score (acute kidney injury network)
    • Time Frame: 24 hours post burn injury
    • Acute Kidney Injury Network stage
  • AKIN Score
    • Time Frame: 48 hours post burn injury
    • Acute Kidney Injury Network stage
  • AKIN Score
    • Time Frame: 72 hours post burn injury
    • Acute Kidney Injury Network stage
  • AKIN Score
    • Time Frame: 96 hours post burn injury
    • Acute Kidney Injury Network stage
  • SOFA score (sequential organ failure assessment)
    • Time Frame: 24 hours post burn injury
    • Sequential Organ Failure Assessment
  • SOFA score
    • Time Frame: 48 hours post burn injury
    • Sequential Organ Failure Assessment
  • SOFA score
    • Time Frame: 72 hours post burn injury
    • Sequential Organ Failure Assessment
  • SOFA score
    • Time Frame: 96 hours post burn injury
    • Sequential Organ Failure Assessment
  • 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
  • Hospital Stay
    • Time Frame: from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
    • Length of hospital stay
  • Survival
    • Time Frame: 28 days post burn injury or death, whichever occurs first
    • In hospital and 28 day survival

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • American Burn Association
  • Collaborator
    • U.S. Army Medical Research Acquisition Activity
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Greenhalgh, MD, Principal Investigator, University of California, Davis
  • Overall Contact(s)
    • Katrina Falwell, BSN, 916-453-2134, kafalwell@ucdavis.edu

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