The Acute Burn Resuscitation Multicenter Prospective Observational Trial

Completed

• Conditions: Burns; Shock

• Registration Number: NCT03144427
• Lead Sponsor: American Burn Association

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").

Study Timeline

• Study Start: 2017-02-24
• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-08
• Status Verified: 2021-07
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fluid resuscitation volume	48 hours post burn injury	Total fluid resuscitation volume in mL/kg/% TBSA burn
albumin : crystalloid ratio	48 hours post burn injury	albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California Davis Medical Center-Regional Burn Center; 🇺🇸 Sacramento, California, United States