MOSES: Procalcitonin Monitoring Sepsis Study

Sponsor

Brahms AG (Industry)

Overall Status

Completed

CT.gov ID

NCT01523717

Collaborator

(none)

858

Enrollment

Locations

Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis Septic Shock

Study Design

Study Type:

Observational

Actual Enrollment :

858 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Outcome Measures

Primary Outcome Measures

28 day all cause mortality [within 28 day safter inlclusion]
participants will be followed up for 28 days

Secondary Outcome Measures

all-cause in-hospital mortality [mortality during hospital stay]
count all death through out stay in the hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Davis Health System	Sacramento	California	United States	95817
2	Northwestern University	Chicago	Illinois	United States	60611
3	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
4	Saint Vincent Hospital	Worcester	Massachusetts	United States	01608
5	Detroit Receiving Hospital	Detroit	Michigan	United States	48201
6	Sinai Grace Hospital	Detroit	Michigan	United States	48201
7	Henry Ford Health System	Detroit	Michigan	United States	48202
8	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
9	New York Methodist Hospital	New York	New York	United States	11215
10	Stony Brook University	New York	New York	United States	11794
11	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
12	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
13	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232