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
  Purpose

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
Severe Sepsis
Septic Shock

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Procalcitonin Decrease Over 72 Hours and Outcome in Patients With Severe Sepsis or Septic Shock

Resource links provided by NLM:


Further study details as provided by Brahms AG:

Primary Outcome Measures:
  • 28 day all cause mortality [ Time Frame: within 28 day safter inlclusion ] [ Designated as safety issue: No ]
    participants will be followed up for 28 days


Secondary Outcome Measures:
  • all-cause in-hospital mortality [ Time Frame: mortality during hospital stay ] [ Designated as safety issue: No ]
    count all death through out stay in the hospital


Biospecimen Retention:   Samples Without DNA

EDTA plasma and serum samples


Enrollment: 858
Study Start Date: December 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sinai Grace Hospital
Detroit, Michigan, United States, 48201
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

No publications provided

Responsible Party: Brahms AG
ClinicalTrials.gov Identifier: NCT01523717     History of Changes
Other Study ID Numbers: brahms-moses
Study First Received: January 19, 2012
Last Updated: March 13, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Sepsis
Shock
Shock, Septic
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on July 01, 2015