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Biomarkers Correlation With Volemia

NCT ID: NCT01858675

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Biomarkers, total blood volume

Group Type EXPERIMENTAL

Biomarkers, red blood cells and plasma assessment

Intervention Type OTHER

Interventions

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Biomarkers, red blood cells and plasma assessment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ThermoFisher Scientific Brahms Biomarkers France

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Bicêtre

Le Krémilin Bicêtre, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 27825364 (View on PubMed)

Other Identifiers

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2011-A01310-41

Identifier Type: -

Identifier Source: org_study_id