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NCT00609414 Clinical Trial

Albumin Use in Burn Patients

Burns Clinical Trial

Official title:
Albumin Use in Burn Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00609414
Other study ID # 04-1392
Secondary ID
Status Completed
Phase N/A
First received January 24, 2008
Last updated April 15, 2011
Start date January 2005
Est. completion date October 2008

Study information
Verified date April 2011
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 460
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Burn Injury, with and without inhalation injury

Exclusion Criteria:

- <20% Total Body Surface Area Burned

- Comfort care only for the burn injury

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre Toronto Ontario
United States Paul and Carol David Foundation Burn Institute, Akron Children's Hospital Akron Ohio
United States Joseph M Still Research Foundation Inc and Doctors Hospital of Augusta Augusta Georgia
United States North Carolina Jaycee Burn Center, University of North Carolina Hospitals Chapel Hill North Carolina
United States Shriners Hospitals for Children Cincinnati Ohio
United States Shands at the University of Florida Burn Center Gainesville Florida
United States Bothin Burn Center, University of Kansas Hospital Kansas City Kansas
United States Arizona Burn Center, Maricopa Medical Center Phoenix Arizona
United States Oregon Burn Center, Legacy Health System Portland Oregon
United States University of Utah Hospitals Burn Center Salt Lake City Utah
United States Bothin Burn Center, Saint Francis Memorial Hospital San Francisco California
United States Regions Hospital Burn Center St. Paul Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Countries where clinical trial is conducted

United States,  Canada, 

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