Procalcitonin Monitoring Sepsis Study (MOSES)

This study is currently recruiting participants.
Verified December 2012 by Brahms AG
Sponsor:
Information provided by (Responsible Party):
Brahms AG
ClinicalTrials.gov Identifier:
NCT01523717
First received: January 19, 2012
Last updated: December 20, 2012
Last verified: December 2012
  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: 360
Study Start Date: December 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523717

Locations
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: Daniel Johnston, RN         dsjohnst@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            
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Sylvia K. Dryer         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: Virginia Krabill, RN         virginia.krabill@carolinashealthcare.org    
Principal Investigator: Jeff Kline, MD            
Sponsors and Collaborators
Brahms AG
  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: December 20, 2012
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 May 23, 2013