Comparative Study of the Protein C Pathway in Septic and Non Septic Patients With Organ Failure

Terminated

• Conditions: Severe Sepsis; Organ Failure

• Registration Number: NCT00361725
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

This is a comparative study performed in 3 groups of patients/subjects: 30 severe sepsis patients, 30 non-septic patients with organ failure, 30 healthy subjects.

The only intervention is a venous blood sampling at the onset of the disease.

The purpose of the study is to compare the PC pathway and expression and inflammatory genes between the 3 groups. The main hypothesis is that systemic inflammatory response and exacerbated coagulation activation are non specific of an infection as a triggering event.

Detailed Description

analysis of the PC pathway

* PC activity

* PS activity

* soluble thrombomodulin

* soluble EPCR

* activated protein C

* quantitative flow cytometry on monocytes (thrombomodulin and EPCR)

* whole blood mRNA (Tissue factor, thrombomodulin and EPCR)

* inflammatory gene expression analysis by MLPA

Study Timeline

• Study Start: 2003-03
• Study Completion: 2003-10
• Status Verified: 2006-06
• Study First Submitted: 2006-08-07
• Study First Submitted QC: 2006-08-07
• Study First Posted: 2006-08-08
• Last Update Submitted: 2006-08-09
• Last Update Posted: 2006-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• severe sepsis patients or:
• non-septic acute organ failure patients or:
• healthy subjects matched for age and sex with severe sepsis patients

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Exclusion Criteria

• criteria for organ failure lasting for more than 24 hours

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified