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Procalcitonin Monitoring Sepsis Study (MOSES)

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ClinicalTrials.gov Identifier: NCT01523717
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Brahms AG

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Severe Sepsis Septic Shock

Study Design
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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 : December 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 28 day all cause mortality [ Time Frame: within 28 day safter inlclusion ]
    participants will be followed up for 28 days


Secondary Outcome Measures :
  1. all-cause in-hospital mortality [ Time Frame: mortality during hospital stay ]
    count all death through out stay in the hospital


Biospecimen Retention:   Samples Without DNA
EDTA plasma and serum samples

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients with severe sepsis or septic shock in the emergency department, medical floor, ICU
Criteria

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523717


Locations
United States, California
University of California Davis Health System
Sacramento, California, United States, 95817
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Saint Vincent Hospital
Worcester, Massachusetts, United States, 01608
United States, Michigan
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Sinai Grace Hospital
Detroit, Michigan, United States, 48201
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New York
New York Methodist Hospital
New York, New York, United States, 11215
Stony Brook University
New York, New York, United States, 11794
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Brahms AG
Investigators
Principal Investigator: Nathan Shapiro, MD Beth Israel Deaconess Medical Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Brahms AG
ClinicalTrials.gov Identifier: NCT01523717     History of Changes
Other Study ID Numbers: brahms-moses
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Brahms AG:
procalcitonin
decrease over 72 hours
severe sepsis
septic shock

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs