Vasoplegic Syndrome of Cardiac SurgeryMicMacNCT07059715
Mic Mac: Micro- and Macrocirculatory Assessment During Cardiac Surgery in Patients at Risk of Vasoplegic Syndrome: A Prospective Study.
An observational study of Vasoplegic Syndrome of Cardiac Surgery, run by European Georges Pompidou Hospital at 1 site in France.
Trial summary
This research focuses on understanding the vasoplegic syndrome after cardiac surgery under extracorporeal circulation and in the aftermath of your surgery in the ICU. The investigators evaluate variations in a number of clinical and biological parameters during cardiac surgery and in the 48 hours following… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vasoplegic Syndrome of Cardiac Surgery
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population is all patients with risk factors at post operative vasoplegia syndrome (3 points or more in "inclusion criteria") who will have a cardiac surgery in the Georges Pompidou European Hospital
Who may be able to join
- Have at least 3 point of the following risk factors for post-body circulation vasoplegic syndrome:
- Acute or chronic heart failure with left ventricular ejection fraction< 40% (1 pt)
- Complex cardiac surgery ( 2 pts)
- Cardiovascular risk factors with a EuroSCORE> 4% (1 pt)
- Chronic Kidney Disease Stage 4
- Type 2 Diabetes Mellitus
Show all 9Show fewer
- Pre-operative heparin treatment
- Hypothyroidism
- Anti-hypertensive treatments including an ACE inhibitor, an angiotensin II receptor antagonist, a beta-blocker or Sacubitril
Who cannot join
- Heart transplantation
- Pre-operative hemodynamic instability
- Pregnant women
- Age <18
- Pre-existing sepsis
- Extracorporeal circulation support
Show all 13Show fewer
- Heartmate/Impella/Carmat patient
- Hypothalamo-hypophyseal pathologies
- Adrenal insufficiency
- Anuric patient
- Guardianship/ curatorship
- Lack of social security coverage
- Opposition to clinical research by patients or their families
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Georges Pompidou European Hospital
Paris, 75015
Helene NOUGUE, MCUPH, +331 56 09 25 94, helene.nougue@aphp.fr
Bernard CHOLLEY, PUPH, +331 56 09 25 15, bernard.cholley@aphp.fr
About this study
Official title: Mic Mac Study: A Prospective Study of Hemodynamic Coherence in Vasoplegic Syndrome After Cardiopulmonary Bypass
This research focuses on understanding the vasoplegic syndrome after cardiac surgery under extracorporeal circulation and in the aftermath of your surgery in the ICU.
The investigators evaluate variations in a number of clinical and biological parameters during cardiac surgery and in the 48 hours following resuscitation. In addition to all the monitors investigators usually use to monitor vital parameters during this type of procedure, investigators use sensors placed on the skin at the earlobe and palm of the hand to assess the quality of blood circulating in the body.
The investigators would like to know if these observations help us to better understand the vasoplegic syndrome (persistent drop in blood pressure requiring the administration of medication to maintain normal blood pressure), a known but poorly understood complication following cardiac surgery under extracorporeal circulation. Extracorporeal circulation is the pump that keeps the blood circulating in your body when the heart is stopped while the surgeon works on the heart.
Read the detailed description
In 2019, 45,236 cardiovascular surgical procedures were performed in France. Despite improved surgical and anesthetic management, cardiovascular surgery continues to be associated with a high mortality rate, with an estimated in-hospital death rate of 5.8%. One of the major complications associated with the patient's condition and the complexity of the surgery is post-extracorporeal circulation vasoplegia syndrome, the incidence of which is estimated at between 5 and 44%. It is associated with a high mortality rate of around 40%. This vasoplegia results in arterial hypotension and organ damage, culminating in multivisceral failure and death. This phenomenon remains poorly understood, as it is extremely complex and multifactorial (vasodilation by pathological nitric oxide production, role of neprilysin, depletion of endogenous catecholamines, alteration of the autonomic nervous system). At present, the only treatments available to manage vasoplegic syndrome are symptomatic. This vasoplegia is the consequence of alterations in microreactivity, leading to a loss of hemodynamic coherence between the macrocirculation and the microcirculation.
The aim of this work is to identify the metabolic pathways responsible for the alterations in vasoreactivity that lead to this loss of hemodynamic coherence, manifesting as hypotension at preserved cardiac output and complicating organ failure.
The investigators will select patients at risk of vasoplegic syndrome after extracorporeal circulation. A detailed assessment of their microcirculatory and macrocirculatory function, combined with blood and urine biomarker assays reflecting circulatory status at the time of sampling, will be carried out before the start of surgery, at the various key stages of cardiovascular surgery, then immediately post-operatively, at 12 hours, 24 hours, and 50 hours from the end of surgery. The monitoring of these parameters, whether or not associated with the appearance of a vasoplegic syndrome following extracorporeal circulation, will enable the investigators to better characterize the elements undergoing modification, and thus to better target the markers and metabolic pathways involved in vasoplegic syndrome, which in turn will enable the proposal of targeted curative or even preventive therapies.
- Conditions
- Vasoplegic Syndrome of Cardiac Surgery
- Keywords
- vasoplegia syndrome, post cardiopulmonary bypass, cardiac surgery
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 |
|---|---|---|
| Patients at risk of vasoplegia syndrome after cardiac surgery | All patients at high risk of vasoplegia syndrome after cardiac surgery because they have cardiopulmonary bypass during the surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood neprilysin activity.
Change from baseline in plasma neprilysin enzymatic activity measure at multiple timepoints with fluorimetry.
Unit of Measure: pmol/mL/min
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in blood neprilysin concentration
Change from baseline in plasma neprilysin concentration measured at multiple timepoints with mass spectrometry.
Unit of Measure: µg/L
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Secondary outcomes (21)
Change in cardiac output.
Change in cardiac output (L/min) assess using transthoracic, transesophageal ultrasound or invasive hemodynamic monitoring (FloTrac, Hemosphere,...).
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery.
Change in mean arterial pressure
Mean arterial pressure is continuously monitor with an arterial catheter and record in mmHg.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change un skin marbling score
Marbling is assessed using a validated ordinal scale (from 0: no marbling to 5: intense marbling) on the anterior knee surface. Score changes is used to evaluate peripheral perfusion and microcirculatory system.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in skin recoloration time.
Skin recoloration time is measured in seconds after fingertip pressure and a return to the initial skin color. This time reflects peripheral perfusion and microcirculatory status.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
vasopressor requirement variation
The dose of vasopressors (e.g: norepinephrine) administered is calculated in µg/kg/min, normalized to body weight and duration, to quantify circulatory support needs.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in tissue oxygen saturation.
Tissue oxygen saturation (StO₂) is measured non-invasively on the forehead using near-infrared spectroscopy (NIRS) technology and reported in percentage (%).
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in transcutaneous tissue CO₂ pressure
Transcutaneous carbon dioxide (PtCO₂) is measured in mmHg using an earlobe sensor maintained at 37°C. This reflects local tissue perfusion and CO₂ clearance.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in plasma lactate concentration.
Plasma lactate levels are measured in mmol/L from arterial blood samples. Lactate serves as a biomarker of tissue hypoperfusion and anaerobic metabolism.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in central venous oxygen saturation
Mixed venous oxygen saturation (SvO₂) is obtained with central veinous blood samples. ScvO₂ is used to detect tissue hypoperfusion. Measure in percentage (%).
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in venous-to-arterial CO₂ gap
The central venous-to-arterial CO₂ gradient is calculated in mmHg by subtracting arterial from venous pCO₂, as an indicator of tissue perfusion.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in plasma creatinine level
Plasma creatinine concentration was measured in µmol/L using standard enzymatic assays to assess renal function.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in B-type natriuretic peptide 1-32
BNP 1-32 concentrations were measured in pmol/L from plasma samples using mass spectrometry technique to assess cardiac strain.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in B-type natriuretic peptide
Plasma B-type natriuretic peptide concentration was measured in ng/L using standard enzymatic assays to assess cardiac strain.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in NT-proBNP concentration
NT-proBNP levels are measured in ngl/L from plasma samples using standard enzymatic assays as a marker of cardiac dysfunction.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in specific NT-proBNP 1-76 concentration
NT-proBNP 1-76 fragment levels are measured in pmol/L from plasma samples using mass spectrometry as a marker of cardiac dysfunction.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in T71-glycosylated proBNP
The percentage of T71-glycosylated proBNP is determined from plasma samples using mass spectrometry, representing the ratio of glycosylated to total proBNP forms.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in vasopressin level
Plasma vasopressin levels are measured in pmol/L by immunoradiology to assess endogenous vasopressor response to circulatory stress.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in aldosterone level.
Plasma aldosterone concentrations are measured in pmol/L using immunoradiology to evaluate the activation of the renin-angiotensin-aldosterone system.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery.
Change in angiotensin II level
Plasma angiotensin II levels are quantified in pmol/L using mass spectrometry techniques to monitor vasoconstrictive hormonal activity and the activation of the renin-angiotensin-aldosterone system.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in endocan level
Plasma endocan concentrations are measured in pmol/L with ELISA techniques to reflect endothelial activation and inflammation in kidney and lung.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in 5-MTP level.
Plasma 5-MTP levels were measured in nmol/L using high-performance liquid chromatography to evaluate to evaluate systemic metabolic stress.
Measured: From enrollment (preoperative) to 48 hours after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start10 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasoplegic Syndrome of Cardiac SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NOUGUE Hélène, European Georges Pompidou Hospital
- Investigators
- Helene NOUGUE, MCUPH, Principal investigator, Georges Pompidou European Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059715
- Sponsor's protocol ID
- 2024-A01235-42
- Acronym
- MicMac
- Status last verified
- Jul 2025
- First submitted
- 21 Feb 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mic Mac Study: A Prospective Study of Hemodynamic Coherence in Vasoplegic Syndrome After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT07059715
- Acronym / sponsor ID
- MicMac / 2024-A01235-42
- Conditions
- Vasoplegic Syndrome of Cardiac Surgery
- Keywords
- vasoplegia syndrome, post cardiopulmonary bypass, cardiac surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jul 2025 (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.
This research focuses on understanding the vasoplegic syndrome after cardiac surgery under extracorporeal circulation and in the aftermath of your surgery in the ICU.
The investigators evaluate variations in a number of clinical and biological parameters during cardiac surgery and in the 48 hours following resuscitation. In addition to all the monitors investigators usually use to monitor vital parameters during this type of procedure, investigators use sensors placed on the skin at the earlobe and palm of the hand to assess the quality of blood circulating in the body.
The investigators would like to know if these observations help us to better understand the vasoplegic syndrome (persistent drop in blood pressure requiring the administration of medication to maintain normal blood pressure), a known but poorly understood complication following cardiac surgery under extracorporeal circulation. Extracorporeal circulation is the pump that keeps the blood circulating in your body when the heart is stopped while the surgeon works on the heart.
Detailed description
In 2019, 45,236 cardiovascular surgical procedures were performed in France. Despite improved surgical and anesthetic management, cardiovascular surgery continues to be associated with a high mortality rate, with an estimated in-hospital death rate of 5.8%. One of the major complications associated with the patient's condition and the complexity of the surgery is post-extracorporeal circulation vasoplegia syndrome, the incidence of which is estimated at between 5 and 44%. It is associated with a high mortality rate of around 40%. This vasoplegia results in arterial hypotension and organ damage, culminating in multivisceral failure and death. This phenomenon remains poorly understood, as it is extremely complex and multifactorial (vasodilation by pathological nitric oxide production, role of neprilysin, depletion of endogenous catecholamines, alteration of the autonomic nervous system). At present, the only treatments available to manage vasoplegic syndrome are symptomatic. This vasoplegia is the consequence of alterations in microreactivity, leading to a loss of hemodynamic coherence between the macrocirculation and the microcirculation.
The aim of this work is to identify the metabolic pathways responsible for the alterations in vasoreactivity that lead to this loss of hemodynamic coherence, manifesting as hypotension at preserved cardiac output and complicating organ failure.
The investigators will select patients at risk of vasoplegic syndrome after extracorporeal circulation. A detailed assessment of their microcirculatory and macrocirculatory function, combined with blood and urine biomarker assays reflecting circulatory status at the time of sampling, will be carried out before the start of surgery, at the various key stages of cardiovascular surgery, then immediately post-operatively, at 12 hours, 24 hours, and 50 hours from the end of surgery. The monitoring of these parameters, whether or not associated with the appearance of a vasoplegic syndrome following extracorporeal circulation, will enable the investigators to better characterize the elements undergoing modification, and thus to better target the markers and metabolic pathways involved in vasoplegic syndrome, which in turn will enable the proposal of targeted curative or even preventive therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at risk of vasoplegia syndrome after cardiac surgery | – | –All patients at high risk of vasoplegia syndrome after cardiac surgery because they have cardiopulmonary bypass during the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is all patients with risk factors at post operative vasoplegia syndrome (3 points or more in "inclusion criteria") who will have a cardiac surgery in the Georges Pompidou European Hospital
Key inclusion criteria (9 listed)
- Have at least 3 point of the following risk factors for post-body circulation vasoplegic syndrome:
- Acute or chronic heart failure with left ventricular ejection fraction< 40% (1 pt)
- Complex cardiac surgery ( 2 pts)
- Cardiovascular risk factors with a EuroSCORE> 4% (1 pt)
- Chronic Kidney Disease Stage 4
Key exclusion criteria (13 listed)
- Heart transplantation
- Pre-operative hemodynamic instability
- Pregnant women
- Age <18
- Pre-existing sepsis
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
Change in blood neprilysin activity.
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change from baseline in plasma neprilysin enzymatic activity measure at multiple timepoints with fluorimetry. Unit of Measure: pmol/mL/min
Change in blood neprilysin concentration
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change from baseline in plasma neprilysin concentration measured at multiple timepoints with mass spectrometry. Unit of Measure: µg/L
21 secondary outcomes
Change in cardiac output.
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery.
Change in mean arterial pressure
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change un skin marbling score
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in skin recoloration time.
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
vasopressor requirement variation
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in tissue oxygen saturation.
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in transcutaneous tissue CO₂ pressure
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in plasma lactate concentration.
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in central venous oxygen saturation
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in venous-to-arterial CO₂ gap
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in plasma creatinine level
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in B-type natriuretic peptide 1-32
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in B-type natriuretic peptide
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in NT-proBNP concentration
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in specific NT-proBNP 1-76 concentration
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in T71-glycosylated proBNP
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in vasopressin level
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in aldosterone level.
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery.
Change in angiotensin II level
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in endocan level
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Change in 5-MTP level.
Time frame: From enrollment (preoperative) to 48 hours after cardiac surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- . Gökdemir, Begüm Nemika, et Nedim Çekmen. " Vasoplegic Syndrome and Anaesthesia: A Narrative Review ". Turkish Journal of Anaesthesiology and Reanimation 51, no 4 (1 august 2023): 280 89.Link provided by the sponsor.
- . Vodovar, Nicolas, Marie-France Séronde, Said Laribi, Etienne Gayat, Johan Lassus, James L. Januzzi, Riadh Boukef, et al. " Elevated Plasma B-Type Natriuretic Peptide Concentrations Directly Inhibit Circulating Neprilysin Activity in Heart Failure ". JALink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Vasoplegic Syndrome of Cardiac Surgery
Active, not recruitingObservational study
Vasoplegic Syndrome in Cardiac Surgery
Vasoplegic Syndrome of Cardiac Surgery
RecruitingObservational study
Evaluation of the HPA Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery
Vasoplegic Syndrome in Adult Cardiac Surgery
Active, not recruitingPhase 3
Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation
Scheduled Cardiac Surgery With Extracorporeal Circulation, Vasoplegic Syndrome
RecruitingPhase 4
Inotropic Effects of Vasopressin Versus Noradrenaline In Patients With Vasoplegic Syndrome After Cardiac Surgery
Vasoplegic Syndrome of Cardiac Surgery
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.
Helene NOUGUE, MCUPH principal investigator
Georges Pompidou European Hospital
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 Vasoplegic Syndrome of Cardiac Surgery, run by European Georges Pompidou Hospital 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 11 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hélène NOUGUE, MCU-PH (+331 56 09 25 94, helene.nougue@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood neprilysin activity. (time frame: From enrollment (preoperative) to 48 hours after cardiac surgery). The study lists 2 primary outcomes in all. 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 11 Jul 2025.