Investigations of New Markers in Patients With Shock
Recruitment status was Recruiting
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).
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Investigations of New Markers in Patients With Shock|
- 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 ]
- Improve the physiopathological knowledge of the patients with shock [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Biological: blood sample
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919685
|Contact: jean GABERTfirstname.lastname@example.org|
|Assistance Publique-Hopitaux de Marseille||Recruiting|
|Contact: Jean GABERT email@example.com|
|Principal Investigator:||jean GABERT||Assistance Publique-Hôpitaux de Marseille|