Severe SepsisMOSESNCT01523717
Procalcitonin Monitoring Sepsis Study
An observational study of Severe Sepsis and Septic Shock, run by Brahms AG at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- How many people
- 858 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2011to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with severe sepsis or septic shock in the emergency department, medical floor, ICU
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Carolinas Medical Center
Charlotte, North Carolina, 28203
Northwestern University
Chicago, Illinois, 60611
Detroit Receiving Hospital
Detroit, Michigan, 48201
Sinai Grace Hospital
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New York Methodist Hospital
New York, New York, 11215
Stony Brook University
New York, New York, 11794
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California Davis Health System
Sacramento, California, 95817
Saint Vincent Hospital
Worcester, Massachusetts, 01608
About this study
Official title: Procalcitonin Decrease Over 72 Hours and Outcome in Patients With Severe Sepsis or Septic Shock
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.
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- procalcitonin, decrease over 72 hours, severe sepsis, septic shock
- Medical subject headings
- Sepsis, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day all cause mortality
participants will be followed up for 28 days
Measured: within 28 day safter inlclusion
Secondary outcomes (1)
all-cause in-hospital mortality
count all death through out stay in the hospital
Measured: mortality during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 858 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brahms AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathan Shapiro, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523717
- Sponsor's protocol ID
- brahms-moses
- Acronym
- MOSES
- Status last verified
- Mar 2015
- First submitted
- 19 Jan 2012
- Last updated
- 17 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin Decrease Over 72 Hours and Outcome in Patients With Severe Sepsis or Septic Shock
- ClinicalTrials.gov ID
- NCT01523717
- Acronym / sponsor ID
- MOSES / brahms-moses
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- procalcitonin, decrease over 72 hours, severe sepsis, septic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 858 participants (actual)
- Lead sponsor
- Brahms AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with severe sepsis or septic shock in the emergency department, medical floor, ICU
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28 day all cause mortality
Time frame: within 28 day safter inlclusion
participants will be followed up for 28 days
1 secondary outcome
all-cause in-hospital mortality
Time frame: mortality during hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Shapiro, MD principal investigator
Beth Israel Deaconess Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Septic Shock, run by Brahms AG at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day all cause mortality (time frame: within 28 day safter inlclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.