Investigations of New Markers in Patients With Shock

NCT ID: NCT00919685

Last Updated: 2014-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31

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).

Conditions

Shock State

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

blood sample

from rest of blood sample collected for other measurements

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jean GABERT

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique-Hôpitaux de Marseille

Locations

Assistance Publique-Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2009-A00105-52

Identifier Type: -

Identifier Source: secondary_id

2009/03

Identifier Type: -

Identifier Source: org_study_id