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Biomarkers Correlation With Volemia (ENVOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01858675
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7 of ICU admission are correlated with Intravascular volume assessed by Cr 51 on red blood cells (Day 2 and Day 7) and by I 125 on albumine Day 7. The correlation of these Biomarkers are also evaluted with other markers such as erythropoietin and catecholamines. 80 ICU patients are included.

Condition or disease Intervention/treatment
Cerebral Hemorrhage Head Injury Non Traumatic Post Surgery Poly Trauma Patients Without Heart Failure Renal Insufficiency Other: Biomarkers, red blood cells and plasma assessment

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Value of Biomarkers on Volemia, Extra and Intra Vascular Varation and Hydroelectrolytic Disorders in Different ICU Patients
Study Start Date : March 2012
Primary Completion Date : November 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Biomarkers, total blood volume Other: Biomarkers, red blood cells and plasma assessment


Outcome Measures

Primary Outcome Measures :
  1. Predictive value of biomarkers changes in Volemia variation [ Time Frame: at Day 2, Day 5 and Day 7 of ICU admission ]
    Correlation with total blood volume(assessed by Cr 51) and biomarkers(Mr proADM, Mr proANP, CT proAVP and proendothelin)changes


Secondary Outcome Measures :
  1. Predictive value of biomarkers changes with efficient volemia, fluid managements and other Markers such erythropoietin [ Time Frame: at Day 2, Day 5 and Day 7 of ICU admission ]
    Correlation with efficient volemia and Biomarkers ( Mr proADM, Mr proANP, CT proAVP and proendothelin)changes.

  2. Predictive value of Biomarkers with APACHE II and SOFA score and Prognosis at ICU discharge [ Time Frame: at Day 2 , Day 5 and Day 7 of ICU admission and at discharge ]
    Correlation of Biomarkers changes with APACHE II and SOFA score and Mortality at Day 2, Day 5 and Day 7 of their ICU admission and at ICU discharge.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 Cerebral Hemorrhage
  • 20 Head Injury
  • 20 post surgery non traumatic non neuro
  • 20 Polytrauma patients

Exclusion Criteria:

  • Heart failure NYHA III or IV
  • Renal insufficiency creatinin clearance < 30 ml/mn
  • age < 18 Y
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858675


Locations
France
Hôpital Bicêtre
Le Krémilin Bicêtre, Ile de France, France, 94 275
Sponsors and Collaborators
ThermoFisher Scientific Brahms Biomarkers France
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ThermoFisher Scientific Brahms Biomarkers France
ClinicalTrials.gov Identifier: NCT01858675     History of Changes
Other Study ID Numbers: 2011-A01310-41
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by ThermoFisher Scientific Brahms Biomarkers France:
ProADM
ProANP
proendothelin
proAVP
Cr 51
Volemia
fluid management
ICU patients
poly trauma patients

Additional relevant MeSH terms:
Heart Failure
Hemorrhage
Renal Insufficiency
Craniocerebral Trauma
Cerebral Hemorrhage
Multiple Trauma
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases