Extracorporeal Circulation; ComplicationsMONSNCT03631797
Preoperative Evaluation of Microcirculation for Prediction of Complications After Cardiac Surgery
A study testing Microvascular reactivity evaluation in people with Extracorporeal Circulation; Complications, run by University Hospital, Angers at 1 site in France.
Trial summary
Cardiac surgery is responsible for many complications. Microcirculation is involved in many of them. The objective of this study is to prospectively investigate the prognostic value of preoperative microcirculatory assessment in patients scheduled for cardiac surgery with CPB for the occurrence of postoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Circulation; Complications
- What is being tested?
- Microvascular reactivity evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2019to 26 Apr 2019
- 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
- Valvular ou coronary elective cardiac surgery under cardiopulmonary bypass
- Fair skin phototype
- Ability to understand the study goal, no dementia.
- Affiliation to the French National Healthcare System
- Voluntary patients who have signed an informed consent
Who cannot join
- Emergency surgery
- Multiple procedures, combined surgery (valvular and coronary)
- Single aortic surgery
- Patient already included in the study (second surgery)
- Patients protected by decision of law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: L'Etude préopératoire de la Microcirculation Pour la prédiction Des Complications après Une Chirurgie Cardiaque Sous Circulation Extracorporelle.
Cardiac surgery is responsible for many complications. Microcirculation is involved in many of them. The objective of this study is to prospectively investigate the prognostic value of preoperative microcirculatory assessment in patients scheduled for cardiac surgery with CPB for the occurrence of postoperative complications.
Microvascular dysfunction is suspected of being involved in postoperative psycho-cognitive decline. The influence of microcirculation on the evolution of psycho-cognitive assessment is also analyzed in this study.
Read the detailed description
Eligible patients are included during the preoperative assessment. Written consent is signed after complete explanation of the protocol.
Patient characteristics as treatments, medical history, and EuroSCORE II are registered. Moreover, intraoperative data is collected. Psycho-cognitive and functional evaluation is made preoperatively.
Microcirculation is evaluated for each patient before surgery. Complications are registered at the end of hospital stay. Psycho-cognitive and functional evaluation is repeated by call 30 days after the surgery.
- Being tested
- Microvascular reactivity evaluation
- Keywords
- Thoracic Surgery, Microcirculation, Endothelium, vascular, Microvascular reactivity, Laser Speckle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microvascular reactivity evaluationProcedure or surgery
Microcirculation will be evaluated for each patient before surgery with a laser speckle contrast imaging (LSCI) placed on the forearm. Tests will be performed for evaluation of endothelium reactivity: Iontophoresis.
| Study group | Role | What they receive |
|---|---|---|
| Microvascular reactivity evaluation | Experimental | Patients referred for a preoperative arterial palmar arches assessment before cardiac valvular or coronary surgery.
Intervention is measurement of microvascular reactivity with a laser speckle contrast imaging before surgery. Receives: Procedure: Microvascular reactivity evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication
Composite criteria and include microcirculation postoperative complications:
- Late surgical re-intervention (greater than 12 hours) for evacuation of pericardial effusion (seeps),
- Surgical wound disunion or surgical site infection,
- Organ failure: SOFA score greater than 2 at 48h,
- Postoperative confusion: assessed using the Confusion Assessment Method (CAM) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU),
- Acute renal failure ≥ stage 2 according to the KDIGO classification,
- Acute lung injury defined as PaO2 <55mmHg in ambient air, PaO2 / FiO2 ratio <250 or Pulse Oxygen Saturation (SpO2) <90% and need for oxygen therapy,
- Atrial fibrillation (excluding patients with permanent Atrial Fibrillation preoperatively),
- Hepatocellular injury (Cytolysis > 10N, Prothrombin rate and Factor V decreased < 60%).
Measured: 30 postoperative days
Secondary outcomes (4)
Evolution of degree of disability
Change of modified Rankin scale
Measured: Inclusion and 30 days after surgery
Functional evolution
Change of ADL score
Measured: Inclusion and 30 days after surgery
Mood evolution
Change of brief Geriatric Depression Scale
Measured: Inclusion and 30 days after surgery
Cognitive evolution
Change of Mc Nair test
Measured: Inclusion and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start14 Jan 2019
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Circulation; ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Samir HENNI, MD PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631797
- Sponsor's protocol ID
- 2018-A2341-54
- Acronym
- MONS
- Status last verified
- Jun 2021
- First submitted
- 30 Jul 2018
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abrard S, Streichenberger A, Riou J, Hersant J, Rineau E, Jacquet-Lagreze M, Fouquet O, Henni S, Rimmele T. Preoperative endothelial dysfunction for the prediction of acute kidney injury after cardiac surgery using cardiopulmonary bypass: a pilot study based on a second analysis of the MONS study. Perioper Med (Lond). 2024 Feb 29;13(1):12. doi: 10.1186/s13741-024-00364-0.
PubMed 38424616Abrard S, Fouquet O, Riou J, Rineau E, Abraham P, Sargentini C, Bigou Y, Baufreton C, Lasocki S, Henni S. Preoperative endothelial dysfunction in cutaneous microcirculation is associated with postoperative organ injury after cardiac surgery using extracorporeal circulation: a prospective cohort study. Ann Intensive Care. 2021 Jan 7;11(1):4. doi: 10.1186/s13613-020-00789-y.
PubMed 33411095
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L'Etude préopératoire de la Microcirculation Pour la prédiction Des Complications après Une Chirurgie Cardiaque Sous Circulation Extracorporelle.
- ClinicalTrials.gov ID
- NCT03631797
- Acronym / sponsor ID
- MONS / 2018-A2341-54
- Keywords
- Thoracic Surgery, Microcirculation, Endothelium, vascular, Microvascular reactivity, Laser Speckle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 15 Aug 2018 (actual)
- 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.
Cardiac surgery is responsible for many complications. Microcirculation is involved in many of them. The objective of this study is to prospectively investigate the prognostic value of preoperative microcirculatory assessment in patients scheduled for cardiac surgery with CPB for the occurrence of postoperative complications.
Microvascular dysfunction is suspected of being involved in postoperative psycho-cognitive decline. The influence of microcirculation on the evolution of psycho-cognitive assessment is also analyzed in this study.
Detailed description
Eligible patients are included during the preoperative assessment. Written consent is signed after complete explanation of the protocol.
Patient characteristics as treatments, medical history, and EuroSCORE II are registered. Moreover, intraoperative data is collected. Psycho-cognitive and functional evaluation is made preoperatively.
Microcirculation is evaluated for each patient before surgery. Complications are registered at the end of hospital stay. Psycho-cognitive and functional evaluation is repeated by call 30 days after the surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microvascular reactivity evaluation | Experimental | Procedure: Microvascular reactivity evaluationPatients referred for a preoperative arterial palmar arches assessment before cardiac valvular or coronary surgery. Intervention is measurement of microvascular reactivity with a laser speckle contrast imaging before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Valvular ou coronary elective cardiac surgery under cardiopulmonary bypass
- Fair skin phototype
- Ability to understand the study goal, no dementia.
- Affiliation to the French National Healthcare System
- Voluntary patients who have signed an informed consent
Key exclusion criteria (5 listed)
- Emergency surgery
- Multiple procedures, combined surgery (valvular and coronary)
- Single aortic surgery
- Patient already included in the study (second surgery)
- Patients protected by decision of law
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 |
|---|---|---|
| Microvascular reactivity evaluationMicrocirculation will be evaluated for each patient before surgery with a laser speckle contrast imaging (LSCI) placed on the forearm. Tests will be performed for evaluation of endothelium reactivity: Iontophoresis. | Procedure or surgery | Microvascular reactivity evaluation |
Primary outcome
Postoperative complication
Time frame: 30 postoperative days
Composite criteria and include microcirculation postoperative complications: * Late surgical re-intervention (greater than 12 hours) for evacuation of pericardial effusion (seeps), * Surgical wound disunion or surgical site infection, * Organ failure: SOFA score greater than 2 at 48h, * Postoperative confusion: assessed using the Confusion Assessment Method (CAM) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), * Acute renal failure ≥ stage 2 according to the KDIGO classification, * Acute lung injury defined as PaO2 <55mmHg in ambient air, PaO2 / FiO2 ratio <250 or Pulse Oxygen Saturation (SpO2) <90% and need for oxygen therapy, * Atrial fibrillation (excluding patients with permanent Atrial Fibrillation preoperatively), * Hepatocellular injury (Cytolysis > 10N, Prothrombin rate and Factor V decreased < 60%).
4 secondary outcomes
Evolution of degree of disability
Time frame: Inclusion and 30 days after surgery
Functional evolution
Time frame: Inclusion and 30 days after surgery
Mood evolution
Time frame: Inclusion and 30 days after surgery
Cognitive evolution
Time frame: Inclusion and 30 days after surgery
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 10 Feb 2023.
- Derived from this study: PubMed 38424616Abrard S, Streichenberger A, Riou J, Hersant J, Rineau E, Jacquet-Lagreze M, Fouquet O, Henni S, Rimmele T. Preoperative endothelial dysfunction for the prediction of acute kidney injury after cardiac surgery using cardiopulmonary bypass: a pilot study based on a second analysis of the MONS study. Perioper Med (Lond). 2024 Feb 29;13(1):12. doi: 10.1186/s13741-024-00364-0.
- Derived from this study: PubMed 33411095Abrard S, Fouquet O, Riou J, Rineau E, Abraham P, Sargentini C, Bigou Y, Baufreton C, Lasocki S, Henni S. Preoperative endothelial dysfunction in cutaneous microcirculation is associated with postoperative organ injury after cardiac surgery using extracorporeal circulation: a prospective cohort study. Ann Intensive Care. 2021 Jan 7;11(1):4. doi: 10.1186/s13613-020-00789-y.
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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.
Samir HENNI, MD PhD principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microvascular reactivity evaluation in people with Extracorporeal Circulation; Complications, run by University Hospital, Angers 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 10 Feb 2023. 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?
Postoperative complication (time frame: 30 postoperative days). 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 NCT03631797, which also lists 2 linked publications.
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 10 Feb 2023.