Severe Sepsis and Septic ShockNCT02391792
Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance
An observational study of Severe Sepsis and Septic Shock, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Severe Sepsis and Septic Shock
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Mar 2020
- How long will I take part?
- 7 Days
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: group patient: patients with septic shock group control: patients without septic shock
Who may be able to join
- Septic shock (patients)
- Without septic shock (control)
- Informed consent
Who cannot join
- Class IV heart failure
- Child-plugh grade C cirrhosis
- Cancer under active treatment
- BMI>35kg/m2
- Moribund patient
- DNR decision
Trial locations and contacts
1 site in 1 country.
Ferhat MEZIANI, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Nouvel Hopital Civil
Strasbourg, Alsace, 67091
Ferhat MEZIANI, MD, PhD, ferhat.meziani@chru-strasbourg.fr
About this study
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).
- Conditions
- Severe Sepsis and Septic Shock
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | patients with septic shock | |
| control | patients without septic shock | |
| healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in number and type of circulating microparticles at 7 days
Measured: Baseline and 7 days
Change from baseline in blood coagulation markers at 7 days
Measured: Baseline and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMar 2013
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Sepsis and Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391792
- Sponsor's protocol ID
- DC2012-1633
- Status last verified
- Aug 2016
- First submitted
- 4 Sep 2014
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Helms J, Severac F, Merdji H, Clere-Jehl R, Francois B, Mercier E, Quenot JP, Meziani F; CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). Performances of disseminated intravascular coagulation scoring systems in septic shock patients. Ann Intensive Care. 2020 Jul 10;10(1):92. doi: 10.1186/s13613-020-00704-5.
PubMed 32651674
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance
- ClinicalTrials.gov ID
- NCT02391792
- Acronym / sponsor ID
- DC2012-1633
- Conditions
- Severe Sepsis and Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 18 Mar 2015 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients | – | –patients with septic shock |
| control | – | –patients without septic shock |
| healthy volunteers | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- group patient: patients with septic shock group control: patients without septic shock
Key inclusion criteria (3 listed)
- Septic shock (patients)
- Without septic shock (control)
- Informed consent
Key exclusion criteria (6 listed)
- Class IV heart failure
- Child-plugh grade C cirrhosis
- Cancer under active treatment
- BMI>35kg/m2
- Moribund patient
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
Change from baseline in number and type of circulating microparticles at 7 days
Time frame: Baseline and 7 days
Change from baseline in blood coagulation markers at 7 days
Time frame: Baseline and 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Derived from this study: PubMed 32651674Helms J, Severac F, Merdji H, Clere-Jehl R, Francois B, Mercier E, Quenot JP, Meziani F; CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). Performances of disseminated intravascular coagulation scoring systems in septic shock patients. Ann Intensive Care. 2020 Jul 10;10(1):92. doi: 10.1186/s13613-020-00704-5.
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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.
Ferhat MEZIANI, MD, PhD contact
1 site 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 University Hospital, Strasbourg, France at 1 site in France.
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 6 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: status not confirmed, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferhat MEZIANI, MD, PhD (ferhat.meziani@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in number and type of circulating microparticles at 7 days (time frame: Baseline and 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02391792, which also lists 1 linked publication.
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 24 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.