NCT04356859

The Acute Burn ResUscitation Multicenter Prospective Trial

Official Title:

The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

Summary

This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area.

Eligibility

Inclusion Criteria:

* Age ≥ 18 years
* Total burn size (second and third degree) is ≥ 25% of the TBSA
* Burn center admission within 12 hours of injury.
* There is a plan for formal fluid resuscitation.

Exclusion Criteria:

* Significant associated trauma
* High voltage (≥ 1000 volts) electrical burns
* Burn wound excision surgery within 48 hours from injury
* Fresh frozen plasma (FFP) given at any time ≤ 48 hours from injury
* Hypertonic saline (HTS) given at any time ≤ 48 hours from injury
* Hydroxyethyl starch (HES) given at any time ≤ 48 hours from injury
* High dose Vitamin C infusion given at any time ≤ 48 hours from injury
* Administration of human albumin prior to randomization
* Palliative comfort measures are instituted ≤ 48 hours from injury
* Pregnancy
* Pre-injury chronic renal insufficiency equal to or greater than stage 3
* Pre-injury chronic hepatic disease (Child-Pugh B or C)
* Pre-injury left ventricular (LV) dysfunction (echocardiography LV grade II-IV or ejection fraction ≤ 35%)

Disease(s) and\or Condition(s)

Burn Injury

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: Albumin Human
    • Description: Addition of albumin during acute resuscitation following burn injury
    • Arm Group Labels: Colloid
Sponsor
  • American Burn Association