Severe Burn InjuryVoLTRABNCT00609700
Balanced Volume Replacement Therapy With Ringer's Acetate Solution in Burn Injury
An observational study of Severe Burn Injury, run by Klinikum St. Georg gGmbH at 1 site in Germany.
Trial summary
This observational study compares the influence of Ringer's Lactate solution and Ringer's Acetate solution on organ function scores following severe burn injury. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Burn Injury
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to Dec 2010
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients within a 24-hours period after severe burn injury
Who may be able to join
- Age >=18 years and <80years
- Burned surface area >20% and <70%
- Burn injury < 24 hours
- Agreement to the study procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This observational study compares the influence of Ringer's Lactate solution and Ringer's Acetate solution on organ function scores following severe burn injury.
Read the 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.
- Conditions
- Severe Burn Injury
- Keywords
- burn injury, volume replacement, Ringer's Lactate solution, Ringer's Acetate solution, volume replacement with crystalloids
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Historical group: patients treated with Ringer's Lactate solution after severe burn injury | |
| 2 | Actual group: patients treated with Ringer's Acetate solution after severe burn injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of SOFA-score from day 3 to day 7 after severe burn injury
Measured: day3, day7, day28, day60
Secondary outcomes (1)
Changes in electrolyte-balance
Measured: day3, day7, day28
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 startDec 2007
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Burn InjuryStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum St. Georg gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Sablotzki, MD, Klinikum St. Georg gGmbH
- Investigators
- Armin R Sablotzki, MD, Principal investigator, Klinikum St. Georg Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609700
- Sponsor's protocol ID
- EK-BR-35/07-1
- Other IDs
- EK-BR-35/07-1
- Acronym
- VoLTRAB
- Status last verified
- Oct 2011
- First submitted
- 25 Jan 2008
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gille J, Klezcewski B, Malcharek M, Raff T, Mogk M, Sablotzki A, Taha H. Safety of resuscitation with Ringer's acetate solution in severe burn (VolTRAB)--an observational trial. Burns. 2014 Aug;40(5):871-80. doi: 10.1016/j.burns.2013.11.021. Epub 2013 Dec 15.
PubMed 24342121
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balanced Volume Replacement Therapy With Ringer's Acetate Solution in Burn Injury
- ClinicalTrials.gov ID
- NCT00609700
- Acronym / sponsor ID
- VoLTRAB / EK-BR-35/07-1
- Conditions
- Severe Burn Injury
- Keywords
- burn injury, volume replacement, Ringer's Lactate solution, Ringer's Acetate solution, volume replacement with crystalloids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Klinikum St. Georg gGmbHUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (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 observational study compares the influence of Ringer's Lactate solution and Ringer's Acetate solution on organ function scores following severe burn injury.
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 design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Historical group: patients treated with Ringer's Lactate solution after severe burn injury |
| 2 | – | –Actual group: patients treated with Ringer's Acetate solution after severe burn injury |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients within a 24-hours period after severe burn injury
Key inclusion criteria (4 listed)
- Age >=18 years and <80years
- Burned surface area >20% and <70%
- Burn injury < 24 hours
- Agreement to the study procedures
Key exclusion criteria (6 listed)
- Burned surface area > 70%
- Expected survival time < 24 hours
- Acute or chronic heart failure NYHA III or IV
- Adult respiratory distress syndrome
- Renal failure
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
Change of SOFA-score from day 3 to day 7 after severe burn injury
Time frame: day3, day7, day28, day60
1 secondary outcome
Changes in electrolyte-balance
Time frame: day3, day7, day28
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 17 Oct 2011.
- Derived from this study: PubMed 24342121Gille J, Klezcewski B, Malcharek M, Raff T, Mogk M, Sablotzki A, Taha H. Safety of resuscitation with Ringer's acetate solution in severe burn (VolTRAB)--an observational trial. Burns. 2014 Aug;40(5):871-80. doi: 10.1016/j.burns.2013.11.021. Epub 2013 Dec 15.
- Homepage of study siteLink provided by the sponsor.
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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.
Armin R Sablotzki, MD principal investigator
Klinikum St. Georg Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Burn Injury, run by Klinikum St. Georg gGmbH at 1 site in Germany.
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 4 inclusion and 6 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 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
What does the primary outcome measure?
Change of SOFA-score from day 3 to day 7 after severe burn injury (time frame: day3, day7, day28, day60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00609700, which also lists 1 linked publication.
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 17 Oct 2011.