NCT00609700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 17, 2011

Status Verified

October 1, 2011

Enrollment Period

2.9 years

First QC Date

January 25, 2008

Last Update Submit

October 14, 2011

Conditions

Severe Burn Injury

Keywords

burn injuryvolume replacementRinger's Lactate solutionRinger's Acetate solutionvolume replacement with crystalloids

Outcome Measures

Primary Outcomes (1)

  • Change of SOFA-score from day 3 to day 7 after severe burn injury

    day3, day7, day28, day60

Secondary Outcomes (1)

  • Changes in electrolyte-balance

    day3, day7, day28

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients within a 24-hours period after severe burn injury

You may qualify if:

  • Age \>=18 years and \<80years
  • Burned surface area \>20% and \<70%
  • Burn injury \< 24 hours
  • Agreement to the study procedures

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum St Georg

Leipzig, Saxony, 04129, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24342121DERIVED

Related Links

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Armin R Sablotzki, MD

    Klinikum St. Georg Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. Dr. med.

Study Record Dates

First Submitted

January 25, 2008

First Posted

February 7, 2008

Study Start

December 1, 2007

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

October 17, 2011

Record last verified: 2011-10

Locations

DE(1)