NCT00361725

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2003

Shorter than P25 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
Last Updated

August 15, 2006

Status Verified

June 1, 2006

First QC Date

August 7, 2006

Last Update Submit

August 9, 2006

Conditions

Severe SepsisOrgan Failure

Keywords

severe sepsisorgan failureactivated protein CthrombomodulinEPCR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • criteria for organ failure lasting for more than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 16374177RESULT

  • 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.

    PMID: 17673691DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Luc DIEHL, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2006

First Posted

August 8, 2006

Study Start

March 1, 2003

Study Completion

October 1, 2003

Last Updated

August 15, 2006

Record last verified: 2006-06