Back to results

Investigations of New Markers in Patients With Shock

Primary Purpose

Shock State

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

blood sample

About this trial

This is an interventional prevention trial for Shock State

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Assistance Publique-Hopitaux de Marseille

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improve the physiopathological knowledge of the patients with shock

Full Information

NCT ID

NCT00919685

First Posted

June 10, 2009

Last Updated

August 28, 2014

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT00919685

Brief Title

Investigations of New Markers in Patients With Shock

Official Title

Investigations of New Markers in Patients With Shock

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shock State

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

blood sample

Intervention Description

from rest of blood sample collected for other measurements

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Improve the physiopathological knowledge of the patients with shock

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

jean GABERT

Organizational Affiliation

Assistance Publique-Hôpitaux de Marseille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assistance Publique-Hopitaux de Marseille

City

Marseille

Country

France

12. IPD Sharing Statement

Learn more about this trial

Investigations of New Markers in Patients With Shock

We'll reach out to this number within 24 hrs