Elective Cardiac SurgeryNCT01748266
Microcirculation of the Thenar Eminence
An observational study of Elective Cardiac Surgery, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB) have been thought to be at the origin of organ dysfunction. Though, few studies correlated microvascular alterations with outcome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Elective Cardiac Surgery
- What is being tested?
- microcirculatory reactivity
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Aug 2011
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB
Who may be able to join
- Age > 18 years
- scheduled for an elective cardiac surgery at high risk of post operative systemic inflammatory response syndrome
Who cannot join
- BMI>35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of the Measure of the StO2 to Estimate the Microcirculatory Disturbances Following Cardiac Surgery With Cardiopulmonary Bypass
Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB) have been thought to be at the origin of organ dysfunction. Though, few studies correlated microvascular alterations with outcome. Investigators aimed at firstly describing microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS parameters with intensive care length of stay and organ dysfunction.
Read the detailed description
40 patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB were included in this prospective observational study. Patients were studied during the first 48 postoperative hours. Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge. Organ dysfunction was assessed with the SOFA score.
- Conditions
- Elective Cardiac Surgery
- Being tested
- microcirculatory reactivity
- Keywords
- StO2, microcirculation, NIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microcirculatory reactivityOther
Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge.
| Study group | Role | What they receive |
|---|---|---|
| microcirculatory reactivity | Patients were studied during the first 48 postoperative hours. Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge. Receives: Other: microcirculatory reactivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
microcirculatory reactivity
Tissue oxygen saturation (StO2) measure by a tissue spectrometer with a 25 mm probe spacing placed on the thenar eminence
Measured: 10 minutes before anesthésia induction
Secondary outcomes (1)
microcirculatory reactivity
Tissue oxygen saturation (StO2) measure by a tissue spectrometer with a 25 mm probe spacing placed on the thenar eminence
Measured: during CPB (30 minutes after the start), and 2, 6, 12, 24 and 48 hours after the end of the CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Cardiac SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerome MOREL, Md, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748266
- Sponsor's protocol ID
- 1008018
- Other IDs
- 2010-A00172-37
- Status last verified
- Dec 2012
- First submitted
- 7 Dec 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Measure of the StO2 to Estimate the Microcirculatory Disturbances Following Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT01748266
- Acronym / sponsor ID
- 1008018
- Conditions
- Elective Cardiac Surgery
- Keywords
- StO2, microcirculation, NIRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 12 Dec 2012 (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.
Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB) have been thought to be at the origin of organ dysfunction. Though, few studies correlated microvascular alterations with outcome. Investigators aimed at firstly describing microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS parameters with intensive care length of stay and organ dysfunction.
Detailed description
40 patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB were included in this prospective observational study. Patients were studied during the first 48 postoperative hours. Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge. Organ dysfunction was assessed with the SOFA score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| microcirculatory reactivity | – | Other: microcirculatory reactivityPatients were studied during the first 48 postoperative hours. Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB
Key inclusion criteria (2 listed)
- Age > 18 years
- scheduled for an elective cardiac surgery at high risk of post operative systemic inflammatory response syndrome
Key exclusion criteria (1 listed)
- BMI>35
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 |
|---|---|---|
| microcirculatory reactivityMicrocirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge. | Other | microcirculatory reactivity |
Primary outcome
microcirculatory reactivity
Time frame: 10 minutes before anesthésia induction
Tissue oxygen saturation (StO2) measure by a tissue spectrometer with a 25 mm probe spacing placed on the thenar eminence
1 secondary outcome
microcirculatory reactivity
Time frame: during CPB (30 minutes after the start), and 2, 6, 12, 24 and 48 hours after the end of the CPB
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 12 Dec 2012.
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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.
Jerome MOREL, 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?
An observational study of Elective Cardiac Surgery, 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 2 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: finished, as of the sponsor's last update on 12 Dec 2012. 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 reactivity (time frame: 10 minutes before anesthésia induction). 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 12 Dec 2012.