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

NCT ID: NCT00609700

Last Updated: 2011-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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

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Severe Burn Injury

Study Design

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Observational Model Type

COHORT

Study Groups

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1

Historical group: patients treated with Ringer's Lactate solution after severe burn injury

No interventions assigned to this group

2

Actual group: patients treated with Ringer's Acetate solution after severe burn injury

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinikum St. Georg gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Armin Sablotzki, MD

prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Armin R Sablotzki, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum St. Georg Leipzig

Locations

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Klinikum St Georg

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 24342121 (View on PubMed)

Related Links

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http://www.sanktgeorg.de

Homepage of study site

Other Identifiers

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EK-BR-35/07-1

Identifier Type: -

Identifier Source: secondary_id

EK-BR-35/07-1

Identifier Type: -

Identifier Source: org_study_id