Investigations of New Markers in Patients With Shock

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00919685
First received: June 10, 2009
Last updated: May 18, 2010
Last verified: May 2010

June 10, 2009
May 18, 2010
May 2009
May 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00919685 on ClinicalTrials.gov Archive Site
Improve the physiopathological knowledge of the patients with shock [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Investigations of New Markers in Patients With Shock
Investigations of New Markers in Patients With Shock

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).

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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Shock State
Biological: blood sample
from rest of blood sample collected for other measurements
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: jean GABERT jean.gabert@ap-hm.fr
France
 
NCT00919685
2009/03, 2009-A00105-52
No
Assistance Publique Hopitaux De Marseille, Direction de la recherche
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: jean GABERT Assistance Publique-Hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP