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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05788120
• Collaborator: (none)
• Enrollment: 600
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Rhythm Disorder	Other: Follow up by phone call

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 Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Patients with refractory cardiogenic shock assisted with ECMO VA	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)

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of ventricular rhythm disorders [day 30]

   ventricular tachycardia, ventricular fibrillation

2. duration of VA ECMO support [day 30]

   duration of VA ECMO support

3. duration of ICU stay [day 30]

   duration of ICU stay

4. duration of mechanical ventilation [day 30]

   duration of mechanical ventilation

5. Number of living patient [day 28, day 360]

   Number of living patient

6. Number of thrombo-embolic complications [day 30]

   acute limb ischemia, circuit thrombosis, membrane thrombosis

7. Number of neurological complications [day 30]

   ischemic and hemorrhagic stroke

8. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT05788120
• Other Study ID Numbers: APHP221056
• First Posted: Mar 28, 2023
• Last Update Posted: Mar 28, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Arrhythmia; Veno-arterial Extra Corporeal Membrane; Oxygenation (VA ECMO); Cardiogenic shock.
• Additional relevant MeSH terms: Shock, Cardiogenic; Arrhythmias, Cardiac

Study Results

No Results Posted as of Mar 28, 2023