Procalcitonin Monitoring Sepsis Study (MOSES)
This study has been completed.
Sponsor:
Brahms AG
Information provided by (Responsible Party):
Brahms AG
ClinicalTrials.gov Identifier:
NCT01523717
First received: January 19, 2012
Last updated: March 13, 2015
Last verified: March 2015
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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
Biospecimen Retention: Samples Without DNA
EDTA plasma and serum samples
| Enrollment: | 858 |
| Study Start Date: | December 2011 |
| Study Completion Date: | March 2014 |
| Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| 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: | March 13, 2015 |
| 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 September 29, 2016