Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance
1 other identifier
observational
300
1 country
1
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedAugust 24, 2016
August 1, 2016
7 years
September 4, 2014
August 23, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in number and type of circulating microparticles at 7 days
Baseline and 7 days
Change from baseline in blood coagulation markers at 7 days
Baseline and 7 days
Study Arms (3)
patients
patients with septic shock
control
patients without septic shock
healthy volunteers
Eligibility Criteria
group patient: patients with septic shock group control: patients without septic shock
You may qualify if:
- Septic shock (patients)
- Without septic shock (control)
- Informed consent
You may not qualify if:
- Class IV heart failure
- Child-plugh grade C cirrhosis
- Cancer under active treatment
- BMI\>35kg/m2
- Moribund patient
- DNR decision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nouvel Hopital Civil
Strasbourg, Alsace, 67091, France
Related Publications (1)
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.
PMID: 32651674DERIVED
Biospecimen
blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 7 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2014
First Posted
March 18, 2015
Study Start
March 1, 2013
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
August 24, 2016
Record last verified: 2016-08