Biomarkers Correlation With Volemia (ENVOL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by ThermoFisher Scientific Brahms Biomarkers France
Sponsor:
Information provided by (Responsible Party):
ThermoFisher Scientific Brahms Biomarkers France
ClinicalTrials.gov Identifier:
NCT01858675
First received: May 13, 2013
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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 Intervention
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 Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ThermoFisher Scientific Brahms Biomarkers France:

Primary Outcome Measures:
  • Predictive value of biomarkers changes in Volemia variation [ Time Frame: at Day 2, Day 5 and Day 7 of ICU admission ] [ Designated as safety issue: No ]
    Correlation with total blood volume(assessed by Cr 51) and biomarkers(Mr proADM, Mr proANP, CT proAVP and proendothelin)changes


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Correlation with efficient volemia and Biomarkers ( Mr proADM, Mr proANP, CT proAVP and proendothelin)changes.

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biomarkers, total blood volume Other: Biomarkers, red blood cells and plasma assessment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858675

Contacts
Contact: Bernard Vigué, Dr MD PHD +33 1 45 21 34 45 bernard.vigue@bct.aphp.fr

Locations
France
Hôpital Bicêtre Recruiting
Le Krémilin Bicêtre, Ile de France, France, 94 275
Contact: Bernard Vigué, Dr MD PHD    +33 1 45 21 34 45    bernard.vigue@bct.aphp.fr   
Sub-Investigator: Pierre- Etienne Leblanc, DR MD         
Principal Investigator: Bernard Vigué, Dr MD PHD         
Sponsors and Collaborators
ThermoFisher Scientific Brahms Biomarkers France
  More Information

No publications provided

Responsible Party: ThermoFisher Scientific Brahms Biomarkers France
ClinicalTrials.gov Identifier: NCT01858675     History of Changes
Other Study ID Numbers: 2011-A01310-41
Study First Received: May 13, 2013
Last Updated: May 16, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on August 20, 2014