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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01858675
Other study ID # 2011-A01310-41
Secondary ID
Status Completed
Phase N/A
First received May 13, 2013
Last updated December 2, 2014
Start date March 2012
Est. completion date December 2014

Study information

Verified date December 2014
Source ThermoFisher Scientific Brahms Biomarkers France
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Biomarkers, red blood cells and plasma assessment


Locations

Country Name City State
France Hôpital Bicêtre Le Krémilin Bicêtre Ile de France

Sponsors (1)

Lead Sponsor Collaborator
ThermoFisher Scientific Brahms Biomarkers France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at Day 2, Day 5 and Day 7 of ICU admission No
Secondary 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. at Day 2, Day 5 and Day 7 of ICU admission No
Secondary 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. at Day 2 , Day 5 and Day 7 of ICU admission and at discharge No
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