MicrocirculationNCT02549378
Study of the Impact of Changes in Carbonemia on Microcirculation in Patients Achieving a Test Hypercapnia
A study testing confocal microscopy in people with Microcirculation and Blood Circulation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The microcirculatory alterations is common in circulatory failure, especially during sepsis. The severity of these changes and their sustainability are responsible of multi organ failure and ultimately death. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Microcirculation, Blood Circulation
- What is being tested?
- confocal microscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Jun 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients from achieving hypercapnia test the CHU of Saint-Etienne
- non smoking
- non diabetic
- affiliated with or entitled to a social security system
- Written consent
Who cannot join
- subjects not performing the test hypercapnia in full
- patients with dermatological pathology at the study area
- patient with Raynaud's syndrome
- Patients with known bleeding disorders
- refusal to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Impact of Changes in Carbonemia on Microcirculation in Patients - A Monocentric Study
The microcirculatory alterations is common in circulatory failure, especially during sepsis. The severity of these changes and their sustainability are responsible of multi organ failure and ultimately death. The optimization of microcirculatory flow could be a central objective of the management of patients hospitalized in intensive care.
Microcirculation includes all blood vessels of a diameter smaller than 100 micrometer. It represents the largest heat exchange surface of the body and is involved in tissue oxygenation. Microcirculatory flow is conditioned by the macrocirculation (heart rate and blood pressure) and the state of the microcirculation (thrombosis, vasoconstriction ...). The role of the CO2 in regulating microcirculatory flow is little studied. A recent work of our team and the oldest work in the literature lead to believe that CO2 has a specific role in modulating microcirculatory flow. No study to date precisely studied the impact of changes in the microcirculatory flow carbonemia .
Read more
The hypocapnia test is carried out in a standardized manner by inhalation of a mixture enriched in CO2 7% allows a significant increase in carbonemia. Hypocapnia will in turn obtained by a calibrated voluntary hyperventilation test.
Direct visualization of microcirculation by confocal microscopy is now considered the gold standard for exploring the microcirculation.
- Conditions
- Microcirculation, Blood Circulation
- Being tested
- confocal microscopy
- Keywords
- microcirculation, confocal microscopy, hypocapnia
- Medical subject headings
- Hypocapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
confocal microscopyDevice
microvessel diameter measured by confocal microscopy
| Study group | Role | What they receive |
|---|---|---|
| patients with a hypercapnia test | Experimental | confocal microscopy patients with a hypercapnia test Receives: Device: confocal microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
microcirculatory flow (cells / min) measured by confocal microscopy
microcirculatory flow (cells / min) measured by confocal microscopy in hypocapnic patients
Measured: Day1
Secondary outcomes (1)
microvessel diameter (micrometer) measured by confocal microscopy
microvessel diameter (micrometer) measured by confocal microscopy in hypocapnic patients
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Gergelé, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549378
- Sponsor's protocol ID
- 1308031
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Changes in Carbonemia on Microcirculation in Patients - A Monocentric Study
- ClinicalTrials.gov ID
- NCT02549378
- Acronym / sponsor ID
- 1308031
- Conditions
- Microcirculation, Blood Circulation
- Keywords
- microcirculation, confocal microscopy, hypocapnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Sep 2015 (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 microcirculatory alterations is common in circulatory failure, especially during sepsis. The severity of these changes and their sustainability are responsible of multi organ failure and ultimately death. The optimization of microcirculatory flow could be a central objective of the management of patients hospitalized in intensive care.
Microcirculation includes all blood vessels of a diameter smaller than 100 micrometer. It represents the largest heat exchange surface of the body and is involved in tissue oxygenation. Microcirculatory flow is conditioned by the macrocirculation (heart rate and blood pressure) and the state of the microcirculation (thrombosis, vasoconstriction ...). The role of the CO2 in regulating microcirculatory flow is little studied. A recent work of our team and the oldest work in the literature lead to believe that CO2 has a specific role in modulating microcirculatory flow. No study to date precisely studied the impact of changes in the microcirculatory flow carbonemia .
The hypocapnia test is carried out in a standardized manner by inhalation of a mixture enriched in CO2 7% allows a significant increase in carbonemia. Hypocapnia will in turn obtained by a calibrated voluntary hyperventilation test.
Direct visualization of microcirculation by confocal microscopy is now considered the gold standard for exploring the microcirculation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a hypercapnia test | Experimental | Device: confocal microscopyconfocal microscopy patients with a hypercapnia test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients from achieving hypercapnia test the CHU of Saint-Etienne
- non smoking
- non diabetic
- affiliated with or entitled to a social security system
- Written consent
Key exclusion criteria (5 listed)
- subjects not performing the test hypercapnia in full
- patients with dermatological pathology at the study area
- patient with Raynaud's syndrome
- Patients with known bleeding disorders
- refusal to 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 |
|---|---|---|
| confocal microscopymicrovessel diameter measured by confocal microscopy | Device | patients with a hypercapnia test |
Primary outcome
microcirculatory flow (cells / min) measured by confocal microscopy
Time frame: Day1
microcirculatory flow (cells / min) measured by confocal microscopy in hypocapnic patients
1 secondary outcome
microvessel diameter (micrometer) measured by confocal microscopy
Time frame: Day1
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 15 Sep 2015.
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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.
Laurent Gergelé, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing confocal microscopy in people with Microcirculation and Blood Circulation, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 inclusion and 5 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 15 Sep 2015. 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?
microcirculatory flow (cells / min) measured by confocal microscopy (time frame: Day1). 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 15 Sep 2015.