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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-10

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Vasoplegic Syndrome of Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes