Biomarkers Correlation With Volemia

Not Applicable

Completed

• Conditions: Poly Trauma Patients Without Heart Failure; Head Injury; Renal Insufficiency; Non Traumatic Post Surgery; Cerebral Hemorrhage
• Interventions: Other: Biomarkers, red blood cells and plasma assessment

• Registration Number: NCT01858675
• Lead Sponsor: ThermoFisher Scientific Brahms Biomarkers France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-21
• Primary Completion: 2014-11
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biomarkers, total blood volume	Biomarkers, red blood cells and plasma assessment	-

Primary Outcome Measures

Name	Time	Method
Predictive value of biomarkers changes in Volemia variation	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

Secondary Outcome Measures

Name	Time	Method
Predictive value of biomarkers changes with efficient volemia, fluid managements and other Markers such erythropoietin	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.
Predictive value of Biomarkers with APACHE II and SOFA score and Prognosis at ICU discharge	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.

Trial Locations

Locations (1)

Hôpital Bicêtre; 🇫🇷 Le Krémilin Bicêtre, Ile de France, France