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NCT01929772 Clinical Trial

German Lactat Clearance in Severe Sepsis

Septic Shock Clinical Trial

— GLASS  

Official title:
German Lactat Clearance in Severe Sepsis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01929772
Other study ID # 12-052
Secondary ID
Status Completed
Phase N/A
First received August 19, 2013
Last updated September 22, 2015
Start date September 2012
Est. completion date April 2015

Study information
Verified date September 2015
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Department for Operative Intensive Care and Intermediate Care - University Hospital Aachen Aachen North Rhine Westfalia

Sponsors (1)
Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Other Mortality Determination of the mortality of the collective after 28 days After 28 days No
Other Duration intensive care unit and hospitalization 28 days No
Primary Lactate Clearance Determination of lactate clearance within 6 hours after diagnosis of severe sepisis and septic shocik Within 6 hours after diagnoses No
Secondary SOFA Score Day of hospitalization, day 7, day 8 No
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