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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-03-31

Study Completion Date

2003-10-31

Brief Summary

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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

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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

Conditions

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Severe Sepsis Organ Failure

Keywords

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severe sepsis organ failure activated protein C thrombomodulin EPCR

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Jean-Luc DIEHL, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

References

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Borgel D, Clauser S, Bornstain C, Bieche 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. doi: 10.1097/01.ccm.0000195014.56254.8a.

Reference Type RESULT

PMID: 16374177 (View on PubMed)

Borgel D, Bornstain C, Reitsma PH, Lerolle N, Gandrille S, Dali-Ali F, Esmon CT, Fagon JY, Aiach M, Diehl JL. A comparative study of the protein C pathway in septic and nonseptic patients with organ failure. Am J Respir Crit Care Med. 2007 Nov 1;176(9):878-85. doi: 10.1164/rccm.200611-1692OC. Epub 2007 Aug 2.

Reference Type DERIVED

PMID: 17673691 (View on PubMed)

Other Identifiers

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PROCAS

Identifier Type: -

Identifier Source: org_study_id