The Acute Burn ResUscitation Multicenter Prospective Trial
Purpose
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.
Condition
- Burn Injury
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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%)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomization will be based on "intent to treat." Consecutively admitted and eligible burn patients will be assigned to one of two treatment groups (Colloid or Crystalloid) within 12 hours of burn injury.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Crystalloid |
Subjects in the crystalloid group will receive fluid resuscitation with Lactated Ringer's titrated each hour to achieve a urine output of 0.5-1mL/kg predicted body weight. |
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|
Active Comparator Colloid |
Subjects in the colloid group will receive fluid resuscitation with Lactated Ringer's and 5% human albumin solution introduced no earlier than 8 hours post burn and no later than 12 hours post burn in a ratio by volume of 1/3 albumin to 2/3 Lactated Ringer's, and titrated each hour to achieve a urine output of 0.5-1mL/kg (milliliter/kilogram) predicted body weight. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- American Burn Association
Detailed Description
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.