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Procalcitonin Monitoring Sepsis Study (MOSES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 19, 2012
First Posted Date February 1, 2012
Last Update Posted Date March 17, 2015
Study Start Date December 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2012)
28 day all cause mortality [ Time Frame: within 28 day safter inlclusion ]
participants will be followed up for 28 days
Original Primary Outcome Measures
 (submitted: January 30, 2012)
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
Current Secondary Outcome Measures
 (submitted: December 20, 2012)
all-cause in-hospital mortality [ Time Frame: mortality during hospital stay ]
count all death through out stay in the hospital
Original Secondary Outcome Measures
 (submitted: January 30, 2012)
28 days mortality [ Time Frame: 28 days after enrolment ]
all cause death will be assessed within 28 days after enrolment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Procalcitonin Monitoring Sepsis Study
Official Title 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 Observational
Study Design 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
  • Severe Sepsis
  • Septic Shock
Intervention 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 Completed
Actual Enrollment
 (submitted: March 13, 2015)
858
Original Estimated Enrollment
 (submitted: January 30, 2012)
242
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01523717
Other Study ID Numbers 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 Brahms AG
Collaborators Not Provided
Investigators
Principal Investigator: Nathan Shapiro, MD Beth Israel Deaconess Medical Center
PRS Account Brahms AG
Verification Date March 2015