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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00361725

Enrollment

Registered

2006-08-08

Start date

2003-03-31

Completion date

2003-10-31

Last updated

2006-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organ Failure, Severe Sepsis

Keywords

severe sepsis, organ failure, activated protein C, thrombomodulin, EPCR

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.

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Outcome results