Renal Insufficiency Clinical Trial
— ENVOLOfficial title:
Predictive Value of Biomarkers on Volemia, Extra and Intra Vascular Varation and Hydroelectrolytic Disorders in Different ICU Patients
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.
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | Hôpital Bicêtre | Le Krémilin Bicêtre | Ile de France |
Lead Sponsor | Collaborator |
---|---|
ThermoFisher Scientific Brahms Biomarkers France |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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