Procalcitonin Monitoring Sepsis Study (MOSES)
This study is currently recruiting participants.
Verified December 2012 by Brahms AG
Sponsor:
Brahms AG
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
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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
| 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