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

Severe Sepsis and Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02391792
• Other study ID #: DC2012-1633
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2014
• Last updated: August 23, 2016
• Start date: March 2013
• Est. completion date: March 2020

Study information

• Verified date: August 2016
• Source: University Hospital, Strasbourg, France
• Contact: Ferhat MEZIANI, MD, PhD
• Email: ferhat.meziani[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Ministère de l'Enseignement supérieur et de la RechercheFrance: Agence régionale de santé
• Study type: Observational [Patient Registry]

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis and Septic Shock
• Shock
• Shock, Septic
• Toxemia

Locations

Country	Name	City	State
France	Nouvel Hopital Civil	Strasbourg	Alsace

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in number and type of circulating microparticles at 7 days		Baseline and 7 days	No
Primary	Change from baseline in blood coagulation markers at 7 days		Baseline and 7 days	No