The Acute Burn ResUscitation Multicenter Prospective Trial
- Registration Number
- NCT04356859
- Lead Sponsor
- American Burn Association
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Colloid Albumin Human 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Occurrence of Abdominal compartment syndrome 48 hours post burn injury Abdominal compartment syndrome 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)
Urine output during resuscitation for burn injury 24 and 48 hours post burn injury Mean hourly urine output during resuscitation for burn injury
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 Limb or abdominal fasciotomy 48 hours post burn injury Limb or abdominal fasciotomy during resuscitation for burn injury
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
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.
Number of crossovers 48 hours post burn injury Number of crossovers between study arms during resuscitation for burn injury
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
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
Survival 28 days post injury and hospital discharge 28 day survival and hospital stay survival
Trial Locations
- Locations (26)
Westchester Medical Center Health Network
🇺🇸Valhalla, New York, United States
Erie County Medical Center
🇺🇸Buffalo, New York, United States
West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Torrance Memorial
🇺🇸Torrance, California, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
University of Miami Health System
🇺🇸Miami, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
Metrohealth Medical Center
🇺🇸Cleveland, Ohio, United States
Regional Burn Center at Harborview
🇺🇸Seattle, Washington, United States
Ascension Via Christi St. Francis
🇺🇸Wichita, Kansas, United States
University of Kansas Health System
🇺🇸Kansas City, Kansas, United States
Hennepin Healthcare
🇺🇸Minneapolis, Minnesota, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States
Arizona Burn Center Valleywise Health
🇺🇸Phoenix, Arizona, United States
Loyola Medicine
🇺🇸Maywood, Illinois, United States
The University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
Cooperman Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of South Florida
🇺🇸Tampa, Florida, United States
Legacy Health
🇺🇸Portland, Oregon, United States
University of Iowa Healthcare
🇺🇸Iowa City, Iowa, United States
University of California Davis, Regional Burn Center
🇺🇸Sacramento, California, United States
Atrium Health Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Florida Health
🇺🇸Gainesville, Florida, United States
University of Wisconsin Health
🇺🇸Madison, Wisconsin, United States