Идёт набор NCT07059715

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

— Наблюдательное Vasoplegic Syndrome of Cardiac Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Vasoplegic Syndrome of Cardiac Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

Change in blood neprilysin activity. [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]
Change in blood neprilysin concentration [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]

Вторичные конечные точки (12)

Change in cardiac output. [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery.]
Change in mean arterial pressure [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]
Change un skin marbling score [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]
Change in skin recoloration time. [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]
vasopressor requirement variation [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]
Change in tissue oxygen saturation. [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]
Change in transcutaneous tissue CO₂ pressure [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]
Change in plasma lactate concentration. [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]
Change in central venous oxygen saturation [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]
Change in venous-to-arterial CO₂ gap [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]
Change in plasma creatinine level [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]
Change in B-type natriuretic peptide 1-32 [Срок оценки: From enrollment (preoperative) to 48 hours after cardiac surgery]

Критерии участия

Критерии включения

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