NCT00919685

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

3.8 years

First QC Date

June 10, 2009

Last Update Submit

August 28, 2014

Conditions

Shock State

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Improve the physiopathological knowledge of the patients with shock

    2 years

Interventions

blood sampleBIOLOGICAL

from rest of blood sample collected for other measurements

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique-Hopitaux de Marseille

Marseille, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • jean GABERT

    Assistance Publique-Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 12, 2009

Study Start

May 1, 2009

Primary Completion

March 1, 2013

Last Updated

August 29, 2014

Record last verified: 2014-08

Locations

FR(1)