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

Recruiting

• Conditions: Cardiac Rhythm Disorder
• Interventions: Other: Follow up by phone call

• Registration Number: NCT05788120
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-03-28
• Study Start: 2023-04-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with refractory cardiogenic shock assisted with ECMO VA	Follow up by phone call	-

Primary Outcome Measures

Name	Time	Method
Number of atrial fibrillation in patients assisted by veno-arterial ECMO.	day 30	Atrial fibrillation will be defined as an episode of AF ≥ 30 minutes or requiring pharmacological or electrical cardioversion.

Secondary Outcome Measures

Name	Time	Method
duration of ICU stay	day 30	duration of ICU stay
Number of ventricular rhythm disorders	day 30	ventricular tachycardia, ventricular fibrillation
duration of VA ECMO support	day 30	duration of VA ECMO support
duration of mechanical ventilation	day 30	duration of mechanical ventilation
Number of living patient	day 28, day 360	Number of living patient
Number of thrombo-embolic complications	day 30	acute limb ischemia, circuit thrombosis, membrane thrombosis
Number of neurological complications	day 30	ischemic and hemorrhagic stroke
Number of bleeding complications	day 30	bleeding requiring transfusion of packed red blood cells (\> 3 units / 24h) or requiring surgical intervention or interventional procedure (digestive or implantation site bleeding, need for revision surgery

Trial Locations

Locations (1)

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France