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

Severe Burn Injury Clinical Trial

— VoLTRAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609700
• Other study ID #: EK-BR-35/07-1
• Secondary ID: EK-BR-35/07-1
• Status: Completed
• Phase: N/A
• First received: January 25, 2008
• Last updated: October 14, 2011
• Start date: December 2007
• Est. completion date: December 2010

Study information

• Verified date: October 2011
• Source: Klinikum St. Georg gGmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Burns
• Severe Burn Injury

Locations

Country	Name	City	State
Germany	Klinikum St Georg	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum St. Georg gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of SOFA-score from day 3 to day 7 after severe burn injury		day3, day7, day28, day60	No
Secondary	Changes in electrolyte-balance		day3, day7, day28	No

External Links

•   Homepage of study site