Procalcitonin Monitoring Sepsis Study

Completed

• Conditions: Severe Sepsis; Septic Shock

• Registration Number: NCT01523717
• Lead Sponsor: Brahms AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 858

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28 day all cause mortality	within 28 day safter inlclusion	participants will be followed up for 28 days

Secondary Outcome Measures

Name	Time	Method
all-cause in-hospital mortality	mortality during hospital stay	count all death through out stay in the hospital

Trial Locations

Locations (13)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Saint Vincent Hospital; 🇺🇸 Worcester, Massachusetts, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of California Davis Health System; 🇺🇸 Sacramento, California, United States

Detroit Receiving Hospital; 🇺🇸 Detroit, Michigan, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

New York Methodist Hospital; 🇺🇸 New York, New York, United States

Sinai Grace Hospital; 🇺🇸 Detroit, Michigan, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Stony Brook University; 🇺🇸 New York, New York, United States