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

Severe Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00361725
• Other study ID #: PROCAS
• Status: Terminated
• Phase: N/A
• First received: August 7, 2006
• Last updated: August 9, 2006
• Start date: March 2003
• Est. completion date: October 2003

Study information

• Verified date: June 2006
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: October 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• severe sepsis patients or:

• non-septic acute organ failure patients or:

• healthy subjects matched for age and sex with severe sepsis patients

Exclusion Criteria:

• criteria for organ failure lasting for more than 24 hours

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Organ Failure
• Severe Sepsis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

References & Publications (1)

Borgel D, Clauser S, Bornstain C, Bièche I, Bissery A, Remones V, Fagon JY, Aiach M, Diehl JL. Elevated growth-arrest-specific protein 6 plasma levels in patients with severe sepsis. Crit Care Med. 2006 Jan;34(1):219-22. — View Citation