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Balanced Volume Replacement Therapy With Ringer's Acetate Solution in Burn Injury (VoLTRAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00609700
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : October 17, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
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

Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Official Title: Balanced Volume Replacement Therapy With Ringer's Acetate Solution in Burn Injury
Study Start Date : December 2007
Primary Completion Date : November 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Change of SOFA-score from day 3 to day 7 after severe burn injury [ Time Frame: day3, day7, day28, day60 ]

Secondary Outcome Measures :
  1. Changes in electrolyte-balance [ Time Frame: day3, day7, day28 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients within a 24-hours period after severe burn injury
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609700


Locations
Germany
Klinikum St Georg
Leipzig, Sachsen, Germany, 04129
Sponsors and Collaborators
Klinikum St. Georg gGmbH
Investigators
Principal Investigator: Armin R Sablotzki, MD Klinikum St. Georg Leipzig
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Armin Sablotzki, MD, prof. Dr. med., Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier: NCT00609700     History of Changes
Other Study ID Numbers: EK-BR-35/07-1
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: October 2011

Keywords provided by Armin Sablotzki, MD, Klinikum St. Georg gGmbH:
burn injury
volume replacement
Ringer's Lactate solution
Ringer's Acetate solution
volume replacement with crystalloids

Additional relevant MeSH terms:
Wounds and Injuries
Burns
Pharmaceutical Solutions