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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier:
NCT00609700
First received: January 25, 2008
Last updated: October 14, 2011
Last verified: October 2011
History of Changes
  Purpose

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
Severe Burn Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Balanced Volume Replacement Therapy With Ringer's Acetate Solution in Burn Injury

Resource links provided by NLM:

MedlinePlus related topics: Burns
U.S. FDA Resources

Further study details as provided by Klinikum St. Georg gGmbH:

Primary Outcome Measures:
  • Change of SOFA-score from day 3 to day 7 after severe burn injury [ Time Frame: day3, day7, day28, day60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in electrolyte-balance [ Time Frame: day3, day7, day28 ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: December 2007
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Homepage of study site  This link exits the ClinicalTrials.gov site

No publications provided

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, EK-BR-35/07-1
Study First Received: January 25, 2008
Last Updated: October 14, 2011
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013