Investigations of New Markers in Patients With Shock

Not Applicable

Completed

• Conditions: Shock State

• Registration Number: NCT00919685
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Shock is a severe deficiency in oxygen at the cell level which could lead to the death.The study was aimed at finding markers of treatment response in patients with shock, with a better accuracy than that of lactate actually used : hypoxia-inducible factor (HIF), circulating DNA (cDNA), and plasma from cells (MPs).

Detailed Description

Shock is a severe deficiency in oxygen at the cell level which could lead to the death. The treatment strategy relies on the profile of plasma lactate level, which the kinetics and metabolism are inadequate for evaluating the treatment efficiency without delay. Hence, it is now critical to identify adequate markers of dysoxia.

The study was aimed at finding markers of treatment response in patients with shock, with a better accuracy than that of lactate.To this purpose, a multiple approach is undertaken with the analysis of 3 independent markers of cellular ischemia : hypoxia-inducible factor (HIF), circulating DNA (cDNA), and plasma from cells (MPs). Indeed, the characteristics of HIF as marker of cell dysoxia, and MPs as markers of cell apoptosis, combined with cDNA seem providing complementary information in order to describe the consequences of shock as well as the response to treatment.

Samples of patients will be collected (from rest of blood sample collected for other measurements) at each step of the management of these patients. The evolution of these markers will be compared with that of lactate plasma levels (standard of care). Subgroup analysis will be undertaken in relation with the cause of shock state (septic, cardiogenic, hemorrhagic).

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2013-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• shock state defined by a rise of plasma lactate level (> 2 mmol/L)and/or refractory low blood pressure in the volume expansion requiring an introduction of catecholamines
• admission in intensive care < 6 hours

Exclusion Criteria

• Pregnancy
• presumed survival lower than 48 hours
• absence of central venous way and arterial catheter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Demonstrate the superiority of at least one of 3 markers (HIF, MPs, cDNA) with regard to plasma lactate level for evaluating the treatment response in patients with shock	2 years

Secondary Outcome Measures

Name	Time	Method
Improve the physiopathological knowledge of the patients with shock	2 years

Trial Locations

Locations (1)

Assistance Publique-Hopitaux de Marseille; 🇫🇷 Marseille, France