Biomarkers Correlation With Volemia
ENVOL
Predictive Value of Biomarkers on Volemia, Extra and Intra Vascular Varation and Hydroelectrolytic Disorders in Different ICU Patients
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 3, 2014
December 1, 2014
2.7 years
May 13, 2013
December 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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
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
Study Arms (1)
Biomarkers, total blood volume
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Cerebral Hemorrhage
- Head Injury
- post surgery non traumatic non neuro
- Polytrauma patients
You may not qualify if:
- Heart failure NYHA III or IV
- Renal insufficiency creatinin clearance \< 30 ml/mn
- age \< 18 Y
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Bicêtre
Le Krémilin Bicêtre, Île-de-France Region, 94 275, France
Related Publications (1)
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.
PMID: 27825364DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 21, 2013
Study Start
March 1, 2012
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
December 3, 2014
Record last verified: 2014-12