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 |
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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
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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.
| Condition or disease |
|---|
| Severe Sepsis Septic Shock |
| Study Type : | Observational |
| Actual Enrollment : | 858 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Procalcitonin Decrease Over 72 Hours and Outcome in Patients With Severe Sepsis or Septic Shock |
| Study Start Date : | December 2011 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | March 2014 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- 28 day all cause mortality [ Time Frame: within 28 day safter inlclusion ]participants will be followed up for 28 days
Secondary Outcome Measures :
- all-cause in-hospital mortality [ Time Frame: mortality during hospital stay ]count all death through out stay in the hospital
Biospecimen Retention: Samples Without DNA
EDTA plasma and serum samples
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
| Sinai Grace Hospital | |
| Detroit, Michigan, United States, 48201 | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| 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 |
| Responsible Party: | Brahms AG |
| ClinicalTrials.gov Identifier: | NCT01523717 |
| Other Study ID Numbers: |
brahms-moses |
| First Posted: | February 1, 2012 Key Record Dates |
| Last Update Posted: | March 17, 2015 |
| Last Verified: | March 2015 |
Keywords provided by Brahms AG:
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procalcitonin decrease over 72 hours severe sepsis septic shock |
Additional relevant MeSH terms:
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Sepsis Toxemia Shock, Septic Shock |
Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |