BurnsNCT00609414
Albumin Use in Burn Patients
An observational study of Burns, run by University of North Carolina, Chapel Hill at 12 sites in 2 countries.
Trial summary
This is a study of why and how physicians use albumin during the first 72 hours after a burn injury. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns
- How many people
- 460 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jan 2005to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have 20% and greater Total Body Surface Area burns who received fluid resuscitation for these injuries.
Who may be able to join
- Burn Injury, with and without inhalation injury
Who cannot join
- <20% Total Body Surface Area Burned
- Comfort care only for the burn injury
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Paul and Carol David Foundation Burn Institute, Akron Children's Hospital
Akron, Ohio, 44308
Joseph M Still Research Foundation Inc and Doctors Hospital of Augusta
Augusta, Georgia, 30909
North Carolina Jaycee Burn Center, University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514
Shriners Hospitals for Children
Cincinnati, Ohio, 45229
Shands at the University of Florida Burn Center
Gainesville, Florida, 32610
Bothin Burn Center, University of Kansas Hospital
Kansas City, Kansas, 66160
Arizona Burn Center, Maricopa Medical Center
Phoenix, Arizona, 85008
Oregon Burn Center, Legacy Health System
Portland, Oregon, 97227
Regions Hospital Burn Center
Saint Paul, Minnesota, 55101
University of Utah Hospitals Burn Center
Salt Lake City, Utah, 84132
Bothin Burn Center, Saint Francis Memorial Hospital
San Francisco, California, 94109
Canada1 site
Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
This is a study of why and how physicians use albumin during the first 72 hours after a burn injury.
Read the 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.
- Conditions
- Burns
- Keywords
- Burns, Albumin, Fluid Resuscitation
- Medical subject headings
- Burns
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Investigators
- Bruce A. Cairns, MD, Principal investigator, North Carolina Jaycee Burn Center, University of North Carolina Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609414
- Sponsor's protocol ID
- 04-1392
- Status last verified
- Apr 2011
- First submitted
- 24 Jan 2008
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin Use in Burn Patients
- ClinicalTrials.gov ID
- NCT00609414
- Acronym / sponsor ID
- 04-1392
- Conditions
- Burns
- Keywords
- Burns, Albumin, Fluid Resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of why and how physicians use albumin during the first 72 hours after a burn injury.
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 design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have 20% and greater Total Body Surface Area burns who received fluid resuscitation for these injuries.
Key inclusion criteria (1 listed)
- Burn Injury, with and without inhalation injury
Key exclusion criteria (2 listed)
- <20% Total Body Surface Area Burned
- Comfort care only for the burn injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce A. Cairns, MD principal investigator
North Carolina Jaycee Burn Center, University of North Carolina Hospitals
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by University of North Carolina, Chapel Hill at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2011.