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Biomarkers Correlation With Volemia (ENVOL)

Primary Purpose

Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Biomarkers, red blood cells and plasma assessment

About this trial

This is an interventional diagnostic trial for Cerebral Hemorrhage focused on measuring ProADM, ProANP, proendothelin, proAVP, Cr 51, Volemia, fluid management, ICU patients, poly trauma patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Bicêtre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biomarkers, total blood volume

Arm Description

Outcomes

Primary Outcome Measures

Predictive value of biomarkers changes in Volemia variation

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

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

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.

Full Information

NCT ID

NCT01858675

First Posted

May 13, 2013

Last Updated

December 2, 2014

Sponsor

ThermoFisher Scientific Brahms Biomarkers France

1. Study Identification

Unique Protocol Identification Number

NCT01858675

Brief Title

Biomarkers Correlation With Volemia

Acronym

ENVOL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ThermoFisher Scientific Brahms Biomarkers France

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure, Renal Insufficiency

Keywords

ProADM, ProANP, proendothelin, proAVP, Cr 51, Volemia, fluid management, ICU patients, poly trauma patients

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biomarkers, total blood volume

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Biomarkers, red blood cells and plasma assessment

Primary Outcome Measure Information:

Title

Predictive value of biomarkers changes in Volemia variation

Description

Correlation with total blood volume(assessed by Cr 51) and biomarkers(Mr proADM, Mr proANP, CT proAVP and proendothelin)changes

Time Frame

at Day 2, Day 5 and Day 7 of ICU admission

Secondary Outcome Measure Information:

Title

Predictive value of biomarkers changes with efficient volemia, fluid managements and other Markers such erythropoietin

Description

Correlation with efficient volemia and Biomarkers ( Mr proADM, Mr proANP, CT proAVP and proendothelin)changes.

Time Frame

at Day 2, Day 5 and Day 7 of ICU admission

Title

Predictive value of Biomarkers with APACHE II and SOFA score and Prognosis at ICU discharge

Description

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.

Time Frame

at Day 2 , Day 5 and Day 7 of ICU admission and at discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Hôpital Bicêtre

City

Le Krémilin Bicêtre

State/Province

Ile de France

ZIP/Postal Code

94 275

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

27825364

Citation

Vigue B, Leblanc PE, Moati F, Pussard E, Foufa H, Rodrigues A, Figueiredo S, Harrois A, Mazoit JX, Rafi H, Duranteau J. Mid-regional pro-adrenomedullin (MR-proADM), a marker of positive fluid balance in critically ill patients: results of the ENVOL study. Crit Care. 2016 Nov 9;20(1):363. doi: 10.1186/s13054-016-1540-x.

Results Reference

derived

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Biomarkers Correlation With Volemia

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