Balanced Volume Replacement Therapy With Ringer's Acetate Solution in Burn Injury (VoLTRAB)
October 14, 2011 updated by: Armin Sablotzki, MD, Klinikum St. Georg gGmbH
This observational study compares the influence of Ringer's Lactate solution and Ringer's Acetate solution on organ function scores following severe burn injury.
Study Overview
Status
Completed
Conditions
Detailed Description
In the early period following severe burn injury volume replacement with high amounts of crystalloids is necessary.
In this study we compare the organ function scores of a historical patient group, treated with Ringer's Lactate solution, with an actual patient population, treated with Ringer's Acetate solution.
Study Type
Observational
Enrollment (Actual)
82
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
-
-
Sachsen
-
Leipzig, Sachsen, Germany, 04129
- Klinikum St Georg
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-
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
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients within a 24-hours period after severe burn injury
Description
Inclusion Criteria:
- Age >=18 years and <80years
- Burned surface area >20% and <70%
- Burn injury < 24 hours
- Agreement to the study procedures
Exclusion Criteria:
- Burned surface area > 70%
- Expected survival time < 24 hours
- Acute or chronic heart failure NYHA III or IV
- Adult respiratory distress syndrome
- Renal failure
- Hepatic failure
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
Cohorts and Interventions
Group / Cohort |
|---|
|
1
Historical group: patients treated with Ringer's Lactate solution after severe burn injury
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|
2
Actual group: patients treated with Ringer's Acetate solution after severe burn injury
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change of SOFA-score from day 3 to day 7 after severe burn injury
Time Frame: day3, day7, day28, day60
|
day3, day7, day28, day60
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in electrolyte-balance
Time Frame: day3, day7, day28
|
day3, day7, day28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Armin R Sablotzki, MD, Klinikum St. Georg Leipzig
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
December 1, 2007
Primary Completion (ACTUAL)
November 1, 2010
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
January 25, 2008
First Submitted That Met QC Criteria
February 6, 2008
First Posted (ESTIMATE)
February 7, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
October 17, 2011
Last Update Submitted That Met QC Criteria
October 14, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK-BR-35/07-1
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.