Procalcitonin Monitoring Sepsis Study (MOSES)
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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
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Sponsor:
Brahms AG
Information provided by (Responsible Party):
Brahms AG
Tracking Information | ||||
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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 |
28 day all cause mortality [ Time Frame: within 28 day safter inlclusion ] participants will be followed up for 28 days
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Original Primary Outcome Measures |
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
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Change History | ||||
Current Secondary Outcome Measures |
all-cause in-hospital mortality [ Time Frame: mortality during hospital stay ] count all death through out stay in the hospital
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Original Secondary Outcome Measures |
28 days mortality [ Time Frame: 28 days after enrolment ] all cause death will be assessed within 28 days after enrolment
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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 |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: EDTA plasma and serum samples
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Sampling Method | Probability Sample | |||
Study Population | adult patients with severe sepsis or septic shock in the emergency department, medical floor, ICU | |||
Condition |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
858 | |||
Original Estimated Enrollment |
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:
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Sex/Gender |
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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 |
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PRS Account | Brahms AG | |||
Verification Date | March 2015 |