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Completed

NCT Number: NCT01858675

Biomarkers Correlation With Volemia

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.

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Key information

Conditions

Cerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Head Injury Hemorrhage Intracranial Hemorrhages Kidney Diseases Male Urogenital Diseases Nervous System Diseases Non Traumatic Post Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Poly Trauma Patients Without Heart Failure Renal Insufficiency Trauma, Nervous System Urogenital Diseases Urologic Diseases Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Bicêtre

Le Krémilin Bicêtre, Île-de-France Region, 94 275, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomarkers, red blood cells and plasma assessment

Other

Primary outcomes

  1. Predictive value of biomarkers changes in Volemia variation

    Time frame: 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 outcomes

  1. Predictive value of biomarkers changes with efficient volemia, fluid managements and other Markers such erythropoietin

    Time frame: 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.

  2. Predictive value of Biomarkers with APACHE II and SOFA score and Prognosis at ICU discharge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ThermoFisher Scientific Brahms Biomarkers France

Industry

Registry information

Official study title

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

Acronym: ENVOL

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 21, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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