Comparing fluid resuscitation methods for severe burn injuries
The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)
This study is testing two different ways to give fluids to adults with severe burns to see which method helps them recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | American Burn Association Academic / other |
| Locations | 26 sites (Phoenix, Arizona and 25 other locations) |
| Trial ID | NCT04356859 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective trial aims to compare two fluid resuscitation strategies in adults with acute burns covering at least 25% of their total body surface area. Participants will be randomly assigned to receive either a colloid strategy (Lactated Ringer's solution plus 5% albumin) or a crystalloid strategy (Lactated Ringer's solution alone). The study will ensure balanced injury severity across groups through block stratification based on age, burn size, and inhalation injury presence. Each group will receive their designated fluids for the first 48 hours post-burn, with adjustments made based on urinary output.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with significant burn injuries covering 25% or more of their body.
Not a fit: Patients with significant associated trauma or specific pre-existing conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve fluid resuscitation protocols for burn patients, potentially leading to better recovery outcomes.
How similar studies have performed: Previous studies have explored fluid resuscitation strategies in burn patients, but this specific comparison of colloid versus crystalloid in a multicenter setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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%)
Where this trial is running
Phoenix, Arizona and 25 other locations
- Arizona Burn Center Valleywise Health — Phoenix, Arizona, United States (Recruiting)
- University of California Davis, Regional Burn Center — Sacramento, California, United States (Recruiting)
- Torrance Memorial — Torrance, California, United States (Not_yet_recruiting)
- University of Florida Health — Gainesville, Florida, United States (Recruiting)
- University of Miami Health System — Miami, Florida, United States (Not_yet_recruiting)
- University of South Florida — Tampa, Florida, United States (Not_yet_recruiting)
- Loyola Medicine — Maywood, Illinois, United States (Not_yet_recruiting)
- University of Iowa Healthcare — Iowa City, Iowa, United States (Recruiting)
- University of Kansas Health System — Kansas City, Kansas, United States (Recruiting)
- Ascension Via Christi St. Francis — Wichita, Kansas, United States (Not_yet_recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Hennepin Healthcare — Minneapolis, Minnesota, United States (Recruiting)
- Cooperman Barnabas Medical Center — Livingston, New Jersey, United States (Recruiting)
- Erie County Medical Center — Buffalo, New York, United States (Recruiting)
- Westchester Medical Center Health Network — Valhalla, New York, United States (Recruiting)
- Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
- University of Cincinnati College of Medicine — Cincinnati, Ohio, United States (Recruiting)
- Metrohealth Medical Center — Cleveland, Ohio, United States (Recruiting)
- Legacy Health — Portland, Oregon, United States (Recruiting)
- West Penn Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- The University of Tennessee Health Science Center — Memphis, Tennessee, United States (Recruiting)
- University of Utah Health — Salt Lake City, Utah, United States (Recruiting)
- Regional Burn Center at Harborview — Seattle, Washington, United States (Recruiting)
- University of Wisconsin Health — Madison, Wisconsin, United States (Recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Not_yet_recruiting)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: David G Greenhalgh, MD — UC Davis Health
- Study coordinator: Katrina Falwell, RN, BSN
- Email: kafalwell@ucdavis.edu
- Phone: 916-453-2134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.