Cardiac ArrestNCT01073098
Evaluation of Muscle StO2 as a Prognostic Factor After Out of Hospital Cardiac Arrest
A study testing Vascular occlusion test in people with Cardiac Arrest, run by Department of Clinical Research and Innovation at 2 sites in France.
Trial summary
Out of hospital cardiac arrest is a major health problem. Prognosis is still poor even after return to spontaneous circulation. The pathophysiology of cardiac arrest implies ischemia-reperfusion and sepsis like syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Vascular occlusion test
- How many people
- 51 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2010to Mar 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out of hospital cardiac arrest
- Patient aged between 18 and 80 years
- Having a Social Security System
Who cannot join
- Pregnant women, lack of appropriate consent
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU de Nice -Hôpital l'Archet
Nice, 06000
Jean-Christophe ORBAN, MD, 00 33 4 92 03 33 00, orban.j@chu-nice.fr
Hervé Hyvernat, MD
- Recruiting
CHU de Nice Hôpital Saint Roch
Nice, 06000
Jean-Christophe ORBAN, MD, +33 4 92 03 33 00, orban.j@chu-nice.fr
Audrey RENARD, MD, +33 4 92 03 33 00, audrey.27.03@free.fr
About this study
Out of hospital cardiac arrest is a major health problem. Prognosis is still poor even after return to spontaneous circulation. The pathophysiology of cardiac arrest implies ischemia-reperfusion and sepsis like syndrome. These phenomenons can lead to microvascular dysfunction explaining probably multi-organ failure after cardiac arrest. Few means allow the exploration of microvascular function in human. Muscle StO2 is a technique allowing the assessment of microvascular function non-invasively. The aim of this study is to evaluate muscle StO2 as a prognostic factor after out of hospital cardiac arrest.
Read the detailed description
Out of hospital cardiac arrest is a major health problem accounting for 375000 deaths each year in Europe. Even after return to spontaneous circulation, survival is poor because of complications such as post-anoxic encephalopathy and multi-organ failure. The pathophysiology of cardiac arrest implies ischemia-reperfusion and sepsis like syndrome. These conditions are frequently associated with microvascular dysfunction that can be the "motor" of multi-organ failure. Few means allow the exploration of microvascular function in human. Recently, StO2, a non-invasive technique assessing microvascular function has been described. This technique measures the tissular saturation of a muscle using the near-infrared spectroscopy technique. It has been described to be a good prognostic factor during haemorrhagic shock state. Dynamic parameters such as reperfusion slope allow discriminating between survivors and survivors after severe sepsis. This dynamic test assesses the microvasculature recruitment that could be a marker of better prognosis. The aim of this study is to evaluate muscle StO2 as a prognostic factor after out of hospital cardiac arrest.
- Conditions
- Cardiac Arrest
- Being tested
- Vascular occlusion test
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular occlusion testOther
Reperfusion slope after vascular occlusion test
What is being measured
The primary outcome is the main question the study is designed to answer.
Reperfusion slope after vascular occlusion test. This parameter will be compared between survivors and non-survivors
Measured: Four measurements : on admission, since the body core temperature reaches 34°, after 24 hours of hypothermia and 48 hours after admission to ICU
Secondary outcomes (1)
Muscle StO2 during the first 2 days Lactatemia during the first 2 days These parameters will be compared between survivors and non-survivors
Measured: Muscle StO2 will be monitored continuously during the first 2 days Lactatemia will be measured every 12 hours until normalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Clinical Research and Innovation
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice
- Responsible party
- Sponsor-investigator, Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
- Investigators
- Jean-Christophe ORBAN, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073098
- Sponsor's protocol ID
- 2009-A01187-50
- Status last verified
- Dec 2011
- First submitted
- 22 Feb 2010
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Muscle StO2 as a Prognostic Factor After Out of Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT01073098
- Acronym / sponsor ID
- 2009-A01187-50
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Department of Clinical Research and InnovationUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 23 Feb 2010 (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.
Out of hospital cardiac arrest is a major health problem. Prognosis is still poor even after return to spontaneous circulation. The pathophysiology of cardiac arrest implies ischemia-reperfusion and sepsis like syndrome. These phenomenons can lead to microvascular dysfunction explaining probably multi-organ failure after cardiac arrest. Few means allow the exploration of microvascular function in human. Muscle StO2 is a technique allowing the assessment of microvascular function non-invasively. The aim of this study is to evaluate muscle StO2 as a prognostic factor after out of hospital cardiac arrest.
Detailed description
Out of hospital cardiac arrest is a major health problem accounting for 375000 deaths each year in Europe. Even after return to spontaneous circulation, survival is poor because of complications such as post-anoxic encephalopathy and multi-organ failure. The pathophysiology of cardiac arrest implies ischemia-reperfusion and sepsis like syndrome. These conditions are frequently associated with microvascular dysfunction that can be the "motor" of multi-organ failure. Few means allow the exploration of microvascular function in human. Recently, StO2, a non-invasive technique assessing microvascular function has been described. This technique measures the tissular saturation of a muscle using the near-infrared spectroscopy technique. It has been described to be a good prognostic factor during haemorrhagic shock state. Dynamic parameters such as reperfusion slope allow discriminating between survivors and survivors after severe sepsis. This dynamic test assesses the microvasculature recruitment that could be a marker of better prognosis. The aim of this study is to evaluate muscle StO2 as a prognostic factor after out of hospital cardiac arrest.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Out of hospital cardiac arrest
- Patient aged between 18 and 80 years
- Having a Social Security System
Key exclusion criteria (1 listed)
- Pregnant women, lack of appropriate consent
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 |
|---|---|---|
| Vascular occlusion testReperfusion slope after vascular occlusion test | Other | – |
Primary outcome
Reperfusion slope after vascular occlusion test. This parameter will be compared between survivors and non-survivors
Time frame: Four measurements : on admission, since the body core temperature reaches 34°, after 24 hours of hypothermia and 48 hours after admission to ICU
1 secondary outcome
Muscle StO2 during the first 2 days Lactatemia during the first 2 days These parameters will be compared between survivors and non-survivors
Time frame: Muscle StO2 will be monitored continuously during the first 2 days Lactatemia will be measured every 12 hours until normalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
Related trials for Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
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.
Jean-Christophe ORBAN, MD principal investigator
Centre Hospitalier Universitaire de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular occlusion test in people with Cardiac Arrest, run by Department of Clinical Research and Innovation at 2 sites 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe ORBAN, MD (+33 4 92 03 33 00, orban.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reperfusion slope after vascular occlusion test. This parameter will be compared between survivors and non-survivors (time frame: Four measurements : on admission, since the body core temperature reaches 34°, after 24 hours of hypothermia and 48 hours after admission to ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2012.