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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient 18 years of age or older

Assistance with VA ECMO

Disqualifiers

Opposition to the use of data.

Persons under legal protection (curators, guardianship), judicially safeguarded.

VA ECMO for refractory cardiac arrest.

Trial population

Major Patients Assisted by VA ECMO in Intensive care

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Follow up by phone call

    Other intervention

    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)

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Patients with refractory cardiogenic shock assisted with ECMO VA1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
day 30

Secondary outcomes

1

Number of ventricular rhythm disorders

ventricular tachycardia, ventricular fibrillation

Time frame
day 30
2

duration of VA ECMO support

duration of VA ECMO support

Time frame
day 30
3

duration of ICU stay

duration of ICU stay

Time frame
day 30
4

duration of mechanical ventilation

duration of mechanical ventilation

Time frame
day 30

Other outcomes

Sponsors and contacts

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