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

This study has been terminated.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00361725
First received: August 7, 2006
Last updated: August 9, 2006
Last verified: June 2006
  Purpose

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.


Condition
Severe Sepsis
Organ Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Comparative Study of the Protein C Pathway in Septic and Non Septic Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Estimated Enrollment: 90
Study Start Date: March 2003
Estimated Study Completion Date: October 2003
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361725

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Jean-Luc DIEHL, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00361725     History of Changes
Other Study ID Numbers: PROCAS
Study First Received: August 7, 2006
Last Updated: August 9, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
severe sepsis
organ failure
activated protein C
thrombomodulin
EPCR

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Protein C
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014