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NCT01523717 Clinical Trial

Procalcitonin Monitoring Sepsis Study

Septic Shock Clinical Trial

— MOSES  

Official title:
Procalcitonin Decrease Over 72 Hours and Outcome in Patients With Severe Sepsis or Septic Shock

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01523717
Other study ID # brahms-moses
Secondary ID
Status Completed
Phase N/A
First received January 19, 2012
Last updated March 13, 2015
Start date December 2011
Est. completion date March 2014

Study information
Verified date March 2015
Source Brahms AG
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate the relationship between a procalcitonin decrease over 72 hours and outcome in patients who have severe sepsis or septic shock.

Recruitment information / eligibility
Status Completed
Enrollment 858
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients (i.e. >18 years of age) diagnosed with severe sepsis or septic shock as defined in Appendix 1, who are already in the ICU or come from the ED, other wards or directly from out of hospital

- Blood sample collection within 12 hours after diagnosis "severe sepsis or septic shock"No prior enrollment into this study

- Written informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Carolinas Medical Center Charlotte North Carolina
United States Northwestern University Chicago Illinois
United States Detroit Receiving Hospital Detroit Michigan
United States Henry Ford Health System Detroit Michigan
United States Sinai Grace Hospital Detroit Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Vanderbilt University Medical Center Nashville Tennessee
United States New York Methodist Hospital New York New York
United States Stony Brook University New York New York
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States University of California Davis Health System Sacramento California
United States Saint Vincent Hospital Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Brahms AG

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 28 day all cause mortality participants will be followed up for 28 days within 28 day safter inlclusion No
Secondary all-cause in-hospital mortality count all death through out stay in the hospital mortality during hospital stay No
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