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

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ClinicalTrials.gov Identifier: NCT02391792
Recruitment Status : Unknown
Verified August 2016 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : March 18, 2015
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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).

Condition or disease
Severe Sepsis and Septic Shock

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance
Study Start Date : March 2013
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Group/Cohort
patients
patients with septic shock
control
patients without septic shock
healthy volunteers



Primary Outcome Measures :
  1. Change from baseline in number and type of circulating microparticles at 7 days [ Time Frame: Baseline and 7 days ]
  2. Change from baseline in blood coagulation markers at 7 days [ Time Frame: Baseline and 7 days ]

Biospecimen Retention:   Samples With DNA
blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
group patient: patients with septic shock group control: patients without septic shock
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391792


Contacts
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Contact: Ferhat MEZIANI, MD, PhD ferhat.meziani@chru-strasbourg.fr

Locations
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France
Nouvel Hopital Civil Recruiting
Strasbourg, Alsace, France, 67091
Contact: Ferhat MEZIANI, MD, PhD       ferhat.meziani@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02391792    
Other Study ID Numbers: DC2012-1633
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Shock
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes