Biomarkers Correlation With Volemia

Renal Insufficiency Clinical Trial

— ENVOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858675
• Other study ID #: 2011-A01310-41
• 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

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

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