Albumin Use in Burn Patients

April 15, 2011 updated by: University of North Carolina, Chapel Hill
This is a study of why and how physicians use albumin during the first 72 hours after a burn injury.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Bruce A. Cairns, MD, North Carolina Jaycee Burn Center, University of North Carolina Hospitals

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 Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

April 18, 2011

Last Update Submitted That Met QC Criteria

April 15, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-1392

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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