Cerebral HemorrhageENVOLNCT01858675
Biomarkers Correlation With Volemia
A study testing Biomarkers, red blood cells and plasma assessment in people with Cerebral Hemorrhage and Head Injury, run by ThermoFisher Scientific Brahms Biomarkers France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery
- What is being tested?
- Biomarkers, red blood cells and plasma assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 Cerebral Hemorrhage
- 20 Head Injury
- 20 post surgery non traumatic non neuro
- 20 Polytrauma patients
Who cannot join
- Heart failure NYHA III or IV
- Renal insufficiency creatinin clearance < 30 ml/mn
- age < 18 Y
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
- Conditions
- Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure, Renal Insufficiency
- Being tested
- Biomarkers, red blood cells and plasma assessment
- Keywords
- ProADM, ProANP, proendothelin, proAVP, Cr 51, Volemia, fluid management, ICU patients, poly trauma patients
- Medical subject headings
- Cerebral Hemorrhage, Craniocerebral Trauma, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers, red blood cells and plasma assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Biomarkers, total blood volume | Experimental | Not described Receives: Other: Biomarkers, red blood cells and plasma assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Correlation with efficient volemia and Biomarkers ( Mr proADM, Mr proANP, CT proAVP and proendothelin)changes.
Measured: 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
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.
Measured: at Day 2 , Day 5 and Day 7 of ICU admission and at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThermoFisher Scientific Brahms Biomarkers France
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858675
- Sponsor's protocol ID
- 2011-A01310-41
- Acronym
- ENVOL
- Status last verified
- Dec 2014
- First submitted
- 13 May 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27825364
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Biomarkers on Volemia, Extra and Intra Vascular Varation and Hydroelectrolytic Disorders in Different ICU Patients
- ClinicalTrials.gov ID
- NCT01858675
- Acronym / sponsor ID
- ENVOL / 2011-A01310-41
- Conditions
- Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure, Renal Insufficiency
- Keywords
- ProADM, ProANP, proendothelin, proAVP, Cr 51, Volemia, fluid management, ICU patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- ThermoFisher Scientific Brahms Biomarkers FranceIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarkers, total blood volume | Experimental | Other: Biomarkers, red blood cells and plasma assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 Cerebral Hemorrhage
- 20 Head Injury
- 20 post surgery non traumatic non neuro
- 20 Polytrauma patients
Key exclusion criteria (4 listed)
- Heart failure NYHA III or IV
- Renal insufficiency creatinin clearance < 30 ml/mn
- age < 18 Y
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarkers, red blood cells and plasma assessment | Other | Biomarkers, total blood volume |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 27825364Vigue 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarkers, red blood cells and plasma assessment in people with Cerebral Hemorrhage and Head Injury, run by ThermoFisher Scientific Brahms Biomarkers France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of biomarkers changes in Volemia variation (time frame: at Day 2, Day 5 and Day 7 of ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01858675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.