The Acute Burn ResUscitation Multicenter Prospective Trial

American Burn Association400 enrolled

Overview

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.

Enrolled subjects will be randomly assigned to either the Colloid Group or the Crystalloid Group. Randomization will be based on an intent-to-treat basis. In order to ensure that the two groups have comparable injury severity at baseline, randomization will be block- stratified based on age (18-50 and \> 50 years), burn size (25-50% and \> 50% TBSA), and presence of inhalation injury confirmed by bronchoscopy (present or absent). In the Colloid Group resuscitation starts with LR and then 5% albumin will be introduced between 8 and 12 hours post burn in a ratio of 1/3 albumin to 2/3 LR. In the Crystalloid Group resuscitation is with LR only. Each group will have their study fluid maintained for the 1st 48 hours post burn and study fluids in each group will be identically titrated to the urinary output.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Burn Injury

Interventions

Albumin HumanDRUG

Addition of albumin during acute resuscitation following burn injury

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%)

Locations (26)

Outcomes

Primary Outcomes

Volume of fluid received during resuscitation for burn injury

Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn

Time frame: 24 hours post burn injury