RECRUITING

The Acute Burn ResUscitation Multicenter Prospective Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

Quick Facts

Study Start:2021-04-22
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04356859

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Total burn size (second and third degree) is ≥ 25% of the TBSA
  3. * Burn center admission within 12 hours of injury.
  4. * There is a plan for formal fluid resuscitation.
  1. * Significant associated trauma
  2. * High voltage (≥ 1000 volts) electrical burns
  3. * Burn wound excision surgery within 48 hours from injury
  4. * Fresh frozen plasma (FFP) given at any time ≤ 48 hours from injury
  5. * Hypertonic saline (HTS) given at any time ≤ 48 hours from injury
  6. * Hydroxyethyl starch (HES) given at any time ≤ 48 hours from injury
  7. * High dose Vitamin C infusion given at any time ≤ 48 hours from injury
  8. * Administration of human albumin prior to randomization
  9. * Palliative comfort measures are instituted ≤ 48 hours from injury
  10. * Pregnancy
  11. * Pre-injury chronic renal insufficiency equal to or greater than stage 3
  12. * Pre-injury chronic hepatic disease (Child-Pugh B or C)
  13. * Pre-injury left ventricular (LV) dysfunction (echocardiography LV grade II-IV or ejection fraction ≤ 35%)

Contacts and Locations

Study Contact

Katrina Falwell, RN, BSN
CONTACT
916-453-2134
kafalwell@ucdavis.edu
Mary Beth Lawless, RN, MS
CONTACT
916-453-2132
mblawless@ucdavis.edu

Principal Investigator

David G Greenhalgh, MD
PRINCIPAL_INVESTIGATOR
UC Davis Health

Study Locations (Sites)

Arizona Burn Center Valleywise Health
Phoenix, Arizona, 85008
United States
University of California Davis, Regional Burn Center
Sacramento, California, 95817
United States
Torrance Memorial
Torrance, California, 90505
United States
University of Florida Health
Gainesville, Florida, 32608
United States
University of Miami Health System
Miami, Florida, 33136
United States
University of South Florida
Tampa, Florida, 33606
United States
Loyola Medicine
Maywood, Illinois, 60153
United States
University of Iowa Healthcare
Iowa City, Iowa, 52242
United States
University of Kansas Health System
Kansas City, Kansas, 66160
United States
Ascension Via Christi St. Francis
Wichita, Kansas, 67214
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Hennepin Healthcare
Minneapolis, Minnesota, 55404
United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Erie County Medical Center
Buffalo, New York, 14215
United States
Westchester Medical Center Health Network
Valhalla, New York, 10595
United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
United States
Metrohealth Medical Center
Cleveland, Ohio, 44109
United States
Legacy Health
Portland, Oregon, 97227
United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States
The University of Tennessee Health Science Center
Memphis, Tennessee, 38163
United States
University of Utah Health
Salt Lake City, Utah, 84132
United States
Regional Burn Center at Harborview
Seattle, Washington, 98014
United States
University of Wisconsin Health
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: American Burn Association

  • David G Greenhalgh, MD, PRINCIPAL_INVESTIGATOR, UC Davis Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-22
Study Completion Date2025-09

Study Record Updates

Study Start Date2021-04-22
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Resuscitation

Additional Relevant MeSH Terms

  • Burn Injury