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Mic Mac: Micro- and Macrocirculatory Assessment During Cardiac Surgery in Patients at Risk of Vasoplegic Syndrome: A Prospective Study.

Mic Mac Study: A Prospective Study of Hemodynamic Coherence in Vasoplegic Syndrome After Cardiopulmonary Bypass

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07059715
Acronym
MicMac
Enrollment
50
Registered
2025-07-11
Start date
2025-02-10
Completion date
2026-12-31
Last updated
2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasoplegic Syndrome of Cardiac Surgery

Keywords

vasoplegia syndrome, post cardiopulmonary bypass, cardiac surgery

Brief 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 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.

Interventions

None listed

Sponsors

European Georges Pompidou Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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 * Pre-operative heparin treatment * Hypothyroidism * Anti-hypertensive treatments including an ACE inhibitor, an angiotensin II receptor antagonist, a beta-blocker or Sacubitril

Exclusion criteria

* Heart transplantation * Pre-operative hemodynamic instability * Pregnant women * Age \<18 * Pre-existing sepsis * Extracorporeal circulation support * 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

Design outcomes

Primary

MeasureTime frameDescription
Change in blood neprilysin activity.From enrollment (preoperative) to 48 hours after cardiac surgeryChange from baseline in plasma neprilysin enzymatic activity measure at multiple timepoints with fluorimetry. Unit of Measure: pmol/mL/min
Change in blood neprilysin concentrationFrom enrollment (preoperative) to 48 hours after cardiac surgeryChange from baseline in plasma neprilysin concentration measured at multiple timepoints with mass spectrometry. Unit of Measure: µg/L

Secondary

MeasureTime frameDescription
Change un skin marbling scoreFrom enrollment (preoperative) to 48 hours after cardiac surgeryMarbling 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.
Change in skin recoloration time.From enrollment (preoperative) to 48 hours after cardiac surgerySkin 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.
vasopressor requirement variationFrom enrollment (preoperative) to 48 hours after cardiac surgeryThe dose of vasopressors (e.g: norepinephrine) administered is calculated in µg/kg/min, normalized to body weight and duration, to quantify circulatory support needs.
Change in tissue oxygen saturation.From enrollment (preoperative) to 48 hours after cardiac surgeryTissue oxygen saturation (StO₂) is measured non-invasively on the forehead using near-infrared spectroscopy (NIRS) technology and reported in percentage (%).
Change in transcutaneous tissue CO₂ pressureFrom enrollment (preoperative) to 48 hours after cardiac surgeryTranscutaneous carbon dioxide (PtCO₂) is measured in mmHg using an earlobe sensor maintained at 37°C. This reflects local tissue perfusion and CO₂ clearance.
Change in plasma lactate concentration.From enrollment (preoperative) to 48 hours after cardiac surgeryPlasma lactate levels are measured in mmol/L from arterial blood samples. Lactate serves as a biomarker of tissue hypoperfusion and anaerobic metabolism.
Change in central venous oxygen saturationFrom enrollment (preoperative) to 48 hours after cardiac surgeryMixed venous oxygen saturation (SvO₂) is obtained with central veinous blood samples. ScvO₂ is used to detect tissue hypoperfusion. Measure in percentage (%).
Change in venous-to-arterial CO₂ gapFrom enrollment (preoperative) to 48 hours after cardiac surgeryThe central venous-to-arterial CO₂ gradient is calculated in mmHg by subtracting arterial from venous pCO₂, as an indicator of tissue perfusion.
Change in plasma creatinine levelFrom enrollment (preoperative) to 48 hours after cardiac surgeryPlasma creatinine concentration was measured in µmol/L using standard enzymatic assays to assess renal function.
Change in cardiac output.From enrollment (preoperative) to 48 hours after cardiac surgery.Change in cardiac output (L/min) assess using transthoracic, transesophageal ultrasound or invasive hemodynamic monitoring (FloTrac, Hemosphere,...).
Change in B-type natriuretic peptideFrom enrollment (preoperative) to 48 hours after cardiac surgeryPlasma B-type natriuretic peptide concentration was measured in ng/L using standard enzymatic assays to assess cardiac strain.
Change in NT-proBNP concentrationFrom enrollment (preoperative) to 48 hours after cardiac surgeryNT-proBNP levels are measured in ngl/L from plasma samples using standard enzymatic assays as a marker of cardiac dysfunction.
Change in specific NT-proBNP 1-76 concentrationFrom enrollment (preoperative) to 48 hours after cardiac surgeryNT-proBNP 1-76 fragment levels are measured in pmol/L from plasma samples using mass spectrometry as a marker of cardiac dysfunction.
Change in T71-glycosylated proBNPFrom enrollment (preoperative) to 48 hours after cardiac surgeryThe percentage of T71-glycosylated proBNP is determined from plasma samples using mass spectrometry, representing the ratio of glycosylated to total proBNP forms.
Change in vasopressin levelFrom enrollment (preoperative) to 48 hours after cardiac surgeryPlasma vasopressin levels are measured in pmol/L by immunoradiology to assess endogenous vasopressor response to circulatory stress.
Change in aldosterone level.From enrollment (preoperative) to 48 hours after cardiac surgery.Plasma aldosterone concentrations are measured in pmol/L using immunoradiology to evaluate the activation of the renin-angiotensin-aldosterone system.
Change in angiotensin II levelFrom enrollment (preoperative) to 48 hours after cardiac surgeryPlasma 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.
Change in endocan levelFrom enrollment (preoperative) to 48 hours after cardiac surgeryPlasma endocan concentrations are measured in pmol/L with ELISA techniques to reflect endothelial activation and inflammation in kidney and lung.
Change in 5-MTP level.From enrollment (preoperative) to 48 hours after cardiac surgeryPlasma 5-MTP levels were measured in nmol/L using high-performance liquid chromatography to evaluate to evaluate systemic metabolic stress.
Change in B-type natriuretic peptide 1-32From enrollment (preoperative) to 48 hours after cardiac surgeryBNP 1-32 concentrations were measured in pmol/L from plasma samples using mass spectrometry technique to assess cardiac strain.
Change in mean arterial pressureFrom enrollment (preoperative) to 48 hours after cardiac surgeryMean arterial pressure is continuously monitor with an arterial catheter and record in mmHg.

Countries

France

Contacts

Primary ContactHélène NOUGUE, MCU-PH
helene.nougue@aphp.fr+331 56 09 25 94
Backup ContactBernard Cholley, PUPH
bernard.cholley@aphp.fr+331 56 09 25 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026