Procalcitonin Monitoring Sepsis Study (MOSES)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Brahms AG

ClinicalTrials.gov Identifier:

NCT01523717

First received: January 19, 2012

Last updated: March 13, 2015

Last verified: March 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

January 19, 2012

Last Updated Date

March 13, 2015

Start Date ^ICMJE

December 2011

Primary Completion Date

March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

28 day all cause mortality [ Time Frame: within 28 day safter inlclusion ]

participants will be followed up for 28 days

Original Primary Outcome Measures ^ICMJE

all cause in-hospital mortality [ Time Frame: duration of hospital stay up to 10 days ]

participants will be followed for the duration of hospital stay, an expected average of 10 days

Change History

Complete list of historical versions of study NCT01523717 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

all-cause in-hospital mortality [ Time Frame: mortality during hospital stay ]

count all death through out stay in the hospital

Original Secondary Outcome Measures ^ICMJE

28 days mortality [ Time Frame: 28 days after enrolment ]

all cause death will be assessed within 28 days after enrolment

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Procalcitonin Monitoring Sepsis Study

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

EDTA plasma and serum samples

Sampling Method

Probability Sample

Study Population

adult patients with severe sepsis or septic shock in the emergency department, medical floor, ICU

Condition ^ICMJE

Severe Sepsis
Septic Shock

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

858

Completion Date

March 2014

Primary Completion Date

March 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01523717

Other Study ID Numbers ^ICMJE

brahms-moses

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Brahms AG

Study Sponsor ^ICMJE

Brahms AG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nathan Shapiro, MD

Beth Israel Deaconess Medical Center

PRS Account

Brahms AG

Verification Date

March 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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