Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock

Официальное название

Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by Extra Corporeal Membrane Oxygenation Veno-arterial (ECMO VA) for Refractory Cardiogenic Shock

Обзор

Brief Summary : Rhythm disorders are a frequent and potentially serious complication of critical patients in the ICU and postoperative cardiac surgery. In particular, atrial fibrillation (AF) is the most common rhythm disorder in patients admitted to the ICU and is associated with excess mortality during acute circulatory failure. In postoperative cardiac surgery, AF affects 15 to 45% of patients. In addition to hemodynamic effects, AF increases the risk of stroke, bleeding, respiratory or renal failure, and doubles mortality at 30 days and 6 months. In the longer term, the recurrence rate of AF within 1 year after hospital discharge is about 50%. Similarly, other rhythm disorders, supraventricular or ventricular, can be life-threatening in ICU patients. While the incidence and complications of rhythm disorders are well documented during sepsis, cardiogenic shock or after cardiac surgery, there are to our knowledge no data on the frequency and complications of rhythm disorders in patients assisted by VA ECMO. The primary objective is to describe the incidence of supraventricular rhythm disorders in patients assisted by VA ECMO.

Подробное описание

This study is an observational study to describe the conditions of occurrence of arrhythmias, particularly atrial fibrillation, in patients supported by VA ECMO, as well as their short-term and long-term prognosis. Patients will be recruited from the intensive care units and CRFs will be completed by the investigators at each of the participating centers. Data will be collected directly from the medical records, except for vital status at 1 year, which may be collected by telephone from the patient by the investigator at the center in the absence of data in the medical record.

Atrial fibrillation episodes will be recorded on a 12-lead electrocardiogram and securely transmitted to the coordinating center. In addition, investigators will send weekly data to the principal investigator for incidence calculation. Patients or their relatives will be informed about the study by an information sheet presented and explained by the investigator or another person authorized to conduct the research. The investigator will record the patient's consent in the patient's medical record.

Вмешательства

• Другое Follow up by phone call
  Centralized review of ECGs by the Pitié-Salpêtrière rhythmology department and collection of vital status at 12 months (if information not available, telephone call to the patient)

Первичные конечные точки

• Number of atrial fibrillation in patients assisted by veno-arterial ECMO. [Срок оценки: day 30]

Вторичные конечные точки (8)

• Number of ventricular rhythm disorders [Срок оценки: day 30]
• duration of VA ECMO support [Срок оценки: day 30]
• duration of ICU stay [Срок оценки: day 30]
• duration of mechanical ventilation [Срок оценки: day 30]
• Number of living patient [Срок оценки: day 28, day 360]
• Number of thrombo-embolic complications [Срок оценки: day 30]
• Number of neurological complications [Срок оценки: day 30]
• Number of bleeding complications [Срок оценки: day 30]

Критерии участия

Критерии включения

• Patient 18 years of age or older
• Assistance with VA ECMO

Критерии исключения

• Opposition to the use of data.
• Persons under legal protection (curators, guardianship), judicially safeguarded.
• VA ECMO for refractory cardiac arrest.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 20 центров

• CHU Angers — Angers
• Hospices Civils de Lyon - Hôpital Louis Pradel — Bron
• CHU Caen Normandie - Hôpital Côte de Nacre — Caen
• CHRU Tours - Hôpital Trousseau — Chambray-lès-Tours
• CHU Dijon Bourgogne - Hôpital François Mitterrand — Dijon
• CHU Grenoble Alpes - Site Nord — Grenoble
• CHU Lille - Institut Cœur Poumon — Lille
• CHU Montpellier - Hôpital Arnaud de Villeneuve — Montpellier
• … и ещё 12 центров

Идентификаторы

NCT: NCT05788120 · APHP221056

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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