- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02391792
Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance
August 23, 2016 updated by: University Hospital, Strasbourg, France
Microparticules (MPs) result from plasma cell membrane remodeling and shedding after cell stimulation or apoptosis.
MPs are know recognized as a pool of bioactive messengers with merging role in pathophysiology of immune and cardiovascular diseases.
MPs have been characterized during septic shock and may contribute to dissemination of pro-inflammatory and procoagulant mediators.
This a prospective observational study of circulating MPs and blood coagulation in septic shock patients admitted in medical intensive care units (ICUs) of four tertiary hospitals at baseline (D1, D2, D3, D4, D7).
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alsace
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Strasbourg, Alsace, France, 67091
- Recruiting
- Nouvel Hôpital Civil
-
Contact:
- Ferhat MEZIANI, MD, PhD
- Email: ferhat.meziani@chru-strasbourg.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
group patient: patients with septic shock group control: patients without septic shock
Description
Inclusion Criteria:
- Septic shock (patients)
- Without septic shock (control)
- Informed consent
Exclusion Criteria:
- Class IV heart failure
- Child-plugh grade C cirrhosis
- Cancer under active treatment
- BMI>35kg/m2
- Moribund patient
- DNR decision
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
healthy volunteers
|
patients
patients with septic shock
|
control
patients without septic shock
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in number and type of circulating microparticles at 7 days
Time Frame: Baseline and 7 days
|
Baseline and 7 days
|
Change from baseline in blood coagulation markers at 7 days
Time Frame: Baseline and 7 days
|
Baseline and 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Anticipated)
March 1, 2020
Study Completion (Anticipated)
March 1, 2020
Study Registration Dates
First Submitted
September 4, 2014
First Submitted That Met QC Criteria
March 17, 2015
First Posted (Estimate)
March 18, 2015
Study Record Updates
Last Update Posted (Estimate)
August 24, 2016
Last Update Submitted That Met QC Criteria
August 23, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DC2012-1633
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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