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GLASS: German Lactat Clearance in Severe Sepsis

Sponsor
RWTH Aachen University (Other)
Overall Status
Completed
CT.gov ID
NCT01929772
Collaborator
(none)
300
Enrollment
1
Location
30.9
Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to investigate if there is a correlation between lactate clearance and the course at patients with severe sepsis and septic shock at german intensive care units.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    German Lactat Clearance in Severe Sepsis
    Study Start Date :
    Sep 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2015
    Actual Study Completion Date :
    Apr 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    severe sepsis or septic shock

    patients with severe sepsis or septic shock

    Outcome Measures

    Primary Outcome Measures

    1. Lactate Clearance [Within 6 hours after diagnoses]

      Determination of lactate clearance within 6 hours after diagnosis of severe sepisis and septic shocik

    Secondary Outcome Measures

    1. SOFA Score [Day of hospitalization, day 7, day 8]

    Other Outcome Measures

    1. Mortality [After 28 days]

      Determination of the mortality of the collective after 28 days

    2. Duration intensive care unit and hospitalization [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with severe sepsis or septic shock

    • signed informed consent

    Exclusion Criteria:

    • severe sepsis or septic schock within 4 weeks before inclusion of study

    • shock of other genesis

    • persons being accomondated in an institution because of court or official order

    • persons being interdependet to the investigator

    • employees of the investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department for Operative Intensive Care and Intermediate Care - University Hospital Aachen Aachen North Rhine Westfalia Germany 52074

    Sponsors and Collaborators

    • RWTH Aachen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RWTH Aachen University
    ClinicalTrials.gov Identifier:
    NCT01929772
    Other Study ID Numbers:
    • 12-052
    First Posted:
    Aug 28, 2013
    Last Update Posted:
    Sep 23, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of Sep 23, 2015