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

August 9, 2006 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment

90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Jean-Luc DIEHL, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion

October 1, 2003

Study Registration Dates

First Submitted

August 7, 2006

First Submitted That Met QC Criteria

August 7, 2006

First Posted (Estimate)

August 8, 2006

Study Record Updates

Last Update Posted (Estimate)

August 15, 2006

Last Update Submitted That Met QC Criteria

August 9, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROCAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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