Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance

NCT ID: NCT02391792

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2020-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Severe Sepsis and Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients

patients with septic shock

No interventions assigned to this group

control

patients without septic shock

No interventions assigned to this group

healthy volunteers

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nouvel Hopital Civil

Strasbourg, Alsace, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Ferhat MEZIANI, MD, PhD

Role: CONTACT

Facility Contacts

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Ferhat MEZIANI, MD, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32651674 (View on PubMed)

Other Identifiers

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DC2012-1633

Identifier Type: -

Identifier Source: org_study_id

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