Procalcitonin Monitoring Sepsis Study (MOSES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Brahms AG
Sponsor:
Information provided by (Responsible Party):
Brahms AG
ClinicalTrials.gov Identifier:
NCT01523717
First received: January 19, 2012
Last updated: November 21, 2013
Last verified: November 2013
  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


Estimated Enrollment: 800
Study Start Date: December 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 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 Recruiting
Sacramento, California, United States, 95817
Contact: Shari Nichols, CCRP       shari.nichols@ucdmc.ucdavis.edu   
Principal Investigator: Edward Panacek, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Allison Chevrier    312-926-6061    a-chevier@northwestern.edu   
Principal Investigator: Mark Courtney, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jeffrey Lewandowski, RN    617-754-2287    jlewando@bidmc.harvard.edu   
Principal Investigator: Nathan Shapiro, MD         
Saint Vincent Hospital Recruiting
Worcester, Massachusetts, United States, 01608
Contact: Jeffrey Lewandowski, SC       jlewando@bidmc.harvard.edu   
Principal Investigator: Nathan Shapiro, MD         
United States, Michigan
Sinai Grace Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Duane Robinson, CCRP    313-966-9265    drobinson@med.wayne.edu   
Principal Investigator: Rober R Sherwin, MD         
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Patrick Medado    313-745-4621    pbmedado@med.wayne.edu   
Principal Investigator: Robert L Sherwin, MD         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Michele L Moyer, RN    313-916-3678    mmoyer1@hfhs.org   
Principal Investigator: Richard M Nowak, MD         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Sylvia K. Dryer    601-815-5533    spowell@umc.edu   
Principal Investigator: Alan E. Jones, MD         
United States, New York
New York Methodist Hospital Recruiting
New York, New York, United States, 11215
Contact: Paris Datillo    718-780-5040    datillo@doctoris.org   
Principal Investigator: Robert Birkhahn, MD         
Stony Brook University Recruiting
New York, New York, United States, 11794
Contact: Maria Taylor, RN    631-444-8345    Maria.taylor@stonybrookmedicine.edu   
Principal Investigator: Adam J Singer, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Melanie Hogg, RN    704-355-4288    melanie.hogg@carolinashealthcare.org   
Principal Investigator: Michael Runyon, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Katie O'Connor    215-662-3908      
Principal Investigator: David F Gaieski, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Donna I Jones    931-265-8838    donna.l.jones@vanderbilt.edu   
Principal Investigator: Wesley H Self, MD         
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: November 21, 2013
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
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014