Albumin Use in Burn Patients

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00609414
First received: January 24, 2008
Last updated: April 15, 2011
Last verified: April 2011
  Purpose

This is a study of why and how physicians use albumin during the first 72 hours after a burn injury.


Condition
Burns

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Albumin Use in Burn Patients

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Enrollment: 460
Study Start Date: January 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

While albumin has been a part of burn resuscitation for many years, its use remains varied and controversial. The purpose of this study is to describe the current practices of albumin administration during the first 72 hours after a burn injury. Participating sites will collect data on patients with at least a 20% Total Body Surface Area (TBSA) burn. Information will be recorded on type and extent of burn injury, basic demographic data, co-morbidities, outcomes and, for the first 72 hours post injury, if albumin was used and why, amount of resuscitation fluids and urine output, and use of vasopressors and diuretics.

Each participating site will retrospectively review 20 charts of consecutive admissions with at least a 20% TBSA burn. In addition, each site will collect data prospectively on 20 more patients with 20% TBSA burns. Prospective data is requested in order to capture as close as possible to "real time" the reasons physicians choose to give albumin. No Protected Health Information (PHI) will be recorded.

Data will be analyzed for patterns of albumin use and reasons for albumin administration.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have 20% and greater Total Body Surface Area burns who received fluid resuscitation for these injuries.

Criteria

Inclusion Criteria:

  • Burn Injury, with and without inhalation injury

Exclusion Criteria:

  • <20% Total Body Surface Area Burned
  • Comfort care only for the burn injury
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609414

Locations
United States, Arizona
Arizona Burn Center, Maricopa Medical Center
Phoenix, Arizona, United States, 85008
United States, California
Bothin Burn Center, Saint Francis Memorial Hospital
San Francisco, California, United States, 94109
United States, Florida
Shands at the University of Florida Burn Center
Gainesville, Florida, United States, 32610
United States, Georgia
Joseph M Still Research Foundation Inc and Doctors Hospital of Augusta
Augusta, Georgia, United States, 30909
United States, Kansas
Bothin Burn Center, University of Kansas Hospital
Kansas City, Kansas, United States, 66160
United States, Minnesota
Regions Hospital Burn Center
St. Paul, Minnesota, United States, 55101
United States, North Carolina
North Carolina Jaycee Burn Center, University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Paul and Carol David Foundation Burn Institute, Akron Children's Hospital
Akron, Ohio, United States, 44308
Shriners Hospitals for Children
Cincinnati, Ohio, United States, 45229
United States, Oregon
Oregon Burn Center, Legacy Health System
Portland, Oregon, United States, 97227
United States, Utah
University of Utah Hospitals Burn Center
Salt Lake City, Utah, United States, 84132
Canada, Ontario
Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Bruce A. Cairns, MD North Carolina Jaycee Burn Center, University of North Carolina Hospitals
  More Information

No publications provided

Responsible Party: Bruce A. Cairns MD, Department of Surgery, University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT00609414     History of Changes
Other Study ID Numbers: 04-1392
Study First Received: January 24, 2008
Last Updated: April 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Burns
Albumin
Fluid Resuscitation

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014