Biomarkers Correlation With Volemia (ENVOL)

December 2, 2014 updated by: ThermoFisher Scientific Brahms Biomarkers France

Predictive Value of Biomarkers on Volemia, Extra and Intra Vascular Varation and Hydroelectrolytic Disorders in Different ICU Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Le Krémilin Bicêtre, Ile de France, France, 94 275
        • Hôpital Bicêtre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Biomarkers, total blood volume
Other: Biomarkers, red blood cells and plasma assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at Day 2, Day 5 and Day 7 of ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at Day 2, Day 5 and Day 7 of ICU admission
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.
at Day 2 , Day 5 and Day 7 of ICU admission and at discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ThermoFisher Scientific Brahms Biomarkers France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 16, 2013

First Posted (ESTIMATE)

May 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A01310-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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