Clinical trial NCT05788120: Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock
Official title: Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by Extra Corporeal Membrane Oxygenation Veno-arterial (ECMO VA) for Refractory Cardiogenic Shock
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Rhythm Disorder
Keywords: Arrhythmia
Veno-arterial Extra Corporeal Membrane
Oxygenation (VA ECMO)
Cardiogenic shock.
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Major Patients Assisted by VA ECMO in Intensive care

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of atrial fibrillation in patients assisted by veno-arterial ECMO.
timeFrame: day 30
Secondary outcomes:
measure: Number of ventricular rhythm disorders
timeFrame: day 30
measure: duration of VA ECMO support
timeFrame: day 30
measure: duration of ICU stay
timeFrame: day 30
measure: duration of mechanical ventilation
timeFrame: day 30
measure: Number of living patient
timeFrame: day 28, day 360
measure: Number of thrombo-embolic complications
timeFrame: day 30
measure: Number of neurological complications
timeFrame: day 30
measure: Number of bleeding complications
timeFrame: day 30
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
Study officials:
References: