Burn Injury
Conditions
Keywords
Resuscitation
Brief 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.
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.
Interventions
DRUGAlbumin Human
Addition of albumin during acute resuscitation following burn injury
Sponsors
United States Department of Defense
American Burn Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of fluid received during resuscitation for burn injury | 24 hours post burn injury | Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine output during resuscitation for burn injury | 24 and 48 hours post burn injury | Mean hourly urine output during resuscitation for burn injury |
| Number of crossovers | 48 hours post burn injury | Number of crossovers between study arms during resuscitation for burn injury |
| Peak lactate and delta lactate | 48 hours post burn injury | peak lactate level and delta lactate (peak lactate minus admission lactate) |
| Peak intra-abdominal pressure (IAP) and delta IAP | 48 hours post burn injury | Peak intra-abdominal pressure (IAP) and delta IAP (peak IAP minus admission IAP) |
| Occurrence of Abdominal compartment syndrome | 48 hours post burn injury | Abdominal compartment syndrome during resuscitation for burn injury |
| Occurrence of Limb or abdominal fasciotomy | 48 hours post burn injury | Limb or abdominal fasciotomy during resuscitation for burn injury |
| Volume of fluid received during resuscitation for burn injury | 48 hours post burn injury | Total resuscitation volume at 48 hours in mL/kg/%TBSA burn. |
| Acute kidney injury (AKI) | 96 hours post burn injury | Diagnosis of AKI |
| Duration of intubation/mechanical ventilation | 96 hours post burn injury | Duration of intubation/mechanical ventilation |
| PaO2/FiO2 ratios | 24, 48, 72, and 96 hours post burn injury | PaO2(partial pressure of oxygen)/FiO2(fraction of inspired oxygen inspired oxygen) ratios |
| Time to wound healing | 7 days post last surgery for grafting of burn injury | Time to wound healing defined as 7 days post last grafting surgery |
| Survival | 28 days post injury and hospital discharge | 28 day survival and hospital stay survival |
| Sequential Organ Failure Assessment (SOFA) score | 48, 72, and 96 hours post burn injury | Assessment of organ function or failure by Sequential Organ Failure Assessment (SOFA)score, with the higher score(s) indicating organ failure |
Countries
Canada, United States
Contacts
Primary ContactKatrina Falwell, RN, BSN
Backup ContactMary Beth Lawless, RN, MS
Outcome results
None listed