Mesenteric IschemiaCITRON4NCT01389947
Microcirculation During Extracorporeal Circulation
An observational study of Mesenteric Ischemia, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Digestive tract is supposed to be the motor of multiple organ failure. In ICU patients, mesenteric ischemia appears even when macrocirculatory parameters are controlled especially in our experience in patients coming in ICU after a cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesenteric Ischemia
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Feb 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who need surgical revascularization of coronary arteries. Patients can not not benefit of percutaneous coronary intervention and need a cardiac surgery of coronary artery bypass grafting
Who may be able to join
- coronary artery bypass grafting without any other surgery
- surgery made under extracorporeal circulation
- the same surgeon is operating each time
- For the heart beating group, inclusion criteria are :
- coronary artery bypass grafting without any other surgery
- surgery performed under "heart beating" conditions.
- no matter about the surgeon that perform surgery
Who cannot join
- age under 18
- pregnancy
- refusing participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Non Major Microcirculation During Extracorporeal Circulation : Relation Between Endothelial Dysfunction and Digestive
Digestive tract is supposed to be the motor of multiple organ failure. In ICU patients, mesenteric ischemia appears even when macrocirculatory parameters are controlled especially in our experience in patients coming in ICU after a cardiac surgery. The investigators suppose that microcirculatory failure develops and results in suffering of non major organs like muscle, skin and digestive tracts. In this study the investigators monitor digestive tract with plasmatic IFABP dosage and microcirculatory circulation with NIRS during a VOT and plasma glycocalyx measurements. The population is composed by patients having coronary artery bypass during cardiopulmonary bypass.
The first aim of this study is to show that digestive tract is suffering with the use of extracorporeal circulation and will be assessed with Plasmatic Intestinal Fatty Acid Binding Protein when IFABP will more than 300 pg/ml ; and with citrullinemia when citrullinemia will be less than 20 micromol/L.
Read more
The second aim is to investigate link between endothelial dysfunction and digestive tract. Endothelial dysfunction is assessed with tissular oxygen saturation before, during and after a vascular occlusion test of 3 minutes (measurement of basal value, desaturation curve, resaturation curve and hyperemic response by measurement of area under curve). Endothelial glycocalyx and NO pathway will be investigate (see under)
Our objective is to enroll 100 patients. The same study will be done in a group of patients who benefit from coronary artery bypass without extracorporeal circulation to see the effects of extracorporeal circulation support.
Read the detailed description
Population study is patients who benefit from coronary artery bypass grafting under extracorporeal circulation support during intervention. Extracorporeal circulation result in SIRS. We aim to study digestive tract during this intervention.
There are 5 times of measurements : under stable hemodynamic conditions and after beginning of anesthesia, just at the end of extracorporeal circulation, about 15 minutes following aortic unclamping and at the end of the Protamine perfusion, about 90 minutes after the end of extracorporeal circulation and the last time measurement 24 hours later.
At each time measurement are done : blood samples to measure Intestinal Fatty Acid Binding Protein, Citrullinemia that are markers for digestive suffering ; blood samples for measurement of Syndecan 1 CD 138 and Heparan Sulfate, two markers of shedding of the endothelial glycocalyx; blood samples for measurement of NOx and GMPc to assess the NO pathway ; measurement of tissular oxygen saturation with a NIRS probe, before, during and after a vascular occlusion test of 3 minutes. Blood samples for hemoglobin, platelets, coagulation evaluation, urea, creatininemia, liver enzymes and pancreatic enzymes will be done at each time.
The vascular occlusion test is done the day before the surgery when patient is awake without any exercise. This is a reference measurement.
- Conditions
- Mesenteric Ischemia
- Keywords
- mesenteric ischemia, extracorporeal circulation, microcirculation, cardiac surgery, IFABP, citrullinemia, glycocalyx, vascular occlusion test, NIRS probe on thenar eminence
- Medical subject headings
- Mesenteric Ischemia, Citrullinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal circulation | Patients who have coronary artery bypass graft performed under extracorporeal circulation | |
| Heart beating group | Patients who have a coronary artery bypass graft without extracorporeal circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proving that digestive failure appears with extracorporeal circulation for cardiac surgery and is more frequent than the 1 to 3 % percent admitted in precedent studies using clinical endpoints.
Digestive suffering will be assessed by clinical measurment (pain, vomiting), classical biologic measurment and new specific measurment (intestinal fatty acid binding protein : IFABP and citrullinemia. Plasmatic IFABP of more than 300 pg/ml and citrullinemia of more than 20 micromol/L are used as cut-off to define intestinal failure.
Microcirculatory will be assessed via a Near InfraRed Spectroscopy (NIRS) probe ajusted on the thenar eminence for the tissular oxygen saturation measurment before, during and after a vascular occlusion test of 3 minutes.
Measured: 24 hours
Secondary outcomes (1)
Study links between endothelial impairment and digestive suffering
Digestive suffering was define before.
Endothelial impairment is define using :
- Tissular Oxygen Saturation during vascular occlusion test. The reasturation curve represents endothelial vasodilatory capacities
- Elevation of Syndecan and Heparan shows the shedding of endothelial glycocalyx We will study the links and the correlation between syndecan and heparan elevation with diminution of resaturation curve and digestive suffering NOx and GMPc will help us for the interpretation of NIRS curves.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenteric IschemiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loic Barrot, Centre Hospitalier Universitaire de Besancon
- Investigators
- Cyril Manzon, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389947
- Sponsor's protocol ID
- P/2010/105
- Acronym
- CITRON4
- Status last verified
- Feb 2012
- First submitted
- 6 May 2011
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Non Major Microcirculation During Extracorporeal Circulation : Relation Between Endothelial Dysfunction and Digestive
- ClinicalTrials.gov ID
- NCT01389947
- Acronym / sponsor ID
- CITRON4 / P/2010/105
- Conditions
- Mesenteric Ischemia
- Keywords
- mesenteric ischemia, extracorporeal circulation, microcirculation, cardiac surgery, IFABP, citrullinemia, glycocalyx, vascular occlusion test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Jul 2011 (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.
Digestive tract is supposed to be the motor of multiple organ failure. In ICU patients, mesenteric ischemia appears even when macrocirculatory parameters are controlled especially in our experience in patients coming in ICU after a cardiac surgery. The investigators suppose that microcirculatory failure develops and results in suffering of non major organs like muscle, skin and digestive tracts. In this study the investigators monitor digestive tract with plasmatic IFABP dosage and microcirculatory circulation with NIRS during a VOT and plasma glycocalyx measurements. The population is composed by patients having coronary artery bypass during cardiopulmonary bypass.
The first aim of this study is to show that digestive tract is suffering with the use of extracorporeal circulation and will be assessed with Plasmatic Intestinal Fatty Acid Binding Protein when IFABP will more than 300 pg/ml ; and with citrullinemia when citrullinemia will be less than 20 micromol/L.
The second aim is to investigate link between endothelial dysfunction and digestive tract. Endothelial dysfunction is assessed with tissular oxygen saturation before, during and after a vascular occlusion test of 3 minutes (measurement of basal value, desaturation curve, resaturation curve and hyperemic response by measurement of area under curve). Endothelial glycocalyx and NO pathway will be investigate (see under)
Our objective is to enroll 100 patients. The same study will be done in a group of patients who benefit from coronary artery bypass without extracorporeal circulation to see the effects of extracorporeal circulation support.
Detailed description
Population study is patients who benefit from coronary artery bypass grafting under extracorporeal circulation support during intervention. Extracorporeal circulation result in SIRS. We aim to study digestive tract during this intervention.
There are 5 times of measurements : under stable hemodynamic conditions and after beginning of anesthesia, just at the end of extracorporeal circulation, about 15 minutes following aortic unclamping and at the end of the Protamine perfusion, about 90 minutes after the end of extracorporeal circulation and the last time measurement 24 hours later.
At each time measurement are done : blood samples to measure Intestinal Fatty Acid Binding Protein, Citrullinemia that are markers for digestive suffering ; blood samples for measurement of Syndecan 1 CD 138 and Heparan Sulfate, two markers of shedding of the endothelial glycocalyx; blood samples for measurement of NOx and GMPc to assess the NO pathway ; measurement of tissular oxygen saturation with a NIRS probe, before, during and after a vascular occlusion test of 3 minutes. Blood samples for hemoglobin, platelets, coagulation evaluation, urea, creatininemia, liver enzymes and pancreatic enzymes will be done at each time.
The vascular occlusion test is done the day before the surgery when patient is awake without any exercise. This is a reference measurement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal circulation | – | –Patients who have coronary artery bypass graft performed under extracorporeal circulation |
| Heart beating group | – | –Patients who have a coronary artery bypass graft without extracorporeal circulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who need surgical revascularization of coronary arteries. Patients can not not benefit of percutaneous coronary intervention and need a cardiac surgery of coronary artery bypass grafting
Key inclusion criteria (7 listed)
- coronary artery bypass grafting without any other surgery
- surgery made under extracorporeal circulation
- the same surgeon is operating each time
- coronary artery bypass grafting without any other surgery
- surgery performed under "heart beating" conditions.
Key exclusion criteria (3 listed)
- age under 18
- pregnancy
- refusing participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proving that digestive failure appears with extracorporeal circulation for cardiac surgery and is more frequent than the 1 to 3 % percent admitted in precedent studies using clinical endpoints.
Time frame: 24 hours
Digestive suffering will be assessed by clinical measurment (pain, vomiting), classical biologic measurment and new specific measurment (intestinal fatty acid binding protein : IFABP and citrullinemia. Plasmatic IFABP of more than 300 pg/ml and citrullinemia of more than 20 micromol/L are used as cut-off to define intestinal failure. Microcirculatory will be assessed via a Near InfraRed Spectroscopy (NIRS) probe ajusted on the thenar eminence for the tissular oxygen saturation measurment before, during and after a vascular occlusion test of 3 minutes.
1 secondary outcome
Study links between endothelial impairment and digestive suffering
Time frame: 24 hours
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 9 Feb 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.
Cyril Manzon principal investigator
Centre Hospitalier Universitaire de Besancon
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 Mesenteric Ischemia, run by Centre Hospitalier Universitaire de Besancon 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 7 inclusion and 3 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 9 Feb 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?
Proving that digestive failure appears with extracorporeal circulation for cardiac surgery and is more frequent than the 1 to 3 % percent admitted in precedent studies using clinical endpoints. (time frame: 24 hours). 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 9 Feb 2012.