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

Cardiac Rhythm Disorder Clinical Trial

— CAVA-ECMO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788120
• Other study ID #: APHP221056
• Status: Recruiting
• Start date: April 2023
• Est. completion date: April 2025

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Adrien Bougle, PhD
• Phone: +33 1 42 16 29 91
• Email: Adrien.bougle[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Rhythm Disorder
• Shock, Cardiogenic

Intervention

Other:
• 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)

Locations

Country	Name	City	State
France	Hôpital Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of atrial fibrillation in patients assisted by veno-arterial ECMO.	Atrial fibrillation will be defined as an episode of AF = 30 minutes or requiring pharmacological or electrical cardioversion.	day 30
Secondary	Number of ventricular rhythm disorders	ventricular tachycardia, ventricular fibrillation	day 30
Secondary	duration of VA ECMO support	duration of VA ECMO support	day 30
Secondary	duration of ICU stay	duration of ICU stay	day 30
Secondary	duration of mechanical ventilation	duration of mechanical ventilation	day 30
Secondary	Number of living patient	Number of living patient	day 28, day 360
Secondary	Number of thrombo-embolic complications	acute limb ischemia, circuit thrombosis, membrane thrombosis	day 30
Secondary	Number of neurological complications	ischemic and hemorrhagic stroke	day 30
Secondary	Number of bleeding complications	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	day 30