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Recruiting NCT05788120

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

Conditions: Cardiac Rhythm Disorder

Sponsor: Assistance Publique - Hôpitaux de Paris

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Follow up by phone call
OTHER
Locations 20
France (20)
CHU Angers
Angers
Hospices Civils de Lyon - Hôpital Louis Pradel
Bron
CHU Caen Normandie - Hôpital Côte de Nacre
Caen
Alina Dr DENISENKO
CHRU Tours - Hôpital Trousseau
Chambray-lès-Tours
NOT_YET_RECRUITING
CHU Dijon Bourgogne - Hôpital François Mitterrand
Dijon
Pierre-Grégoire Pr GUINOT
CHU Grenoble Alpes - Site Nord
Grenoble
Alexandre Dr BEHOUCHE
CHU Lille - Institut Cœur Poumon
Lille
NOT_YET_RECRUITING
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier
Phillipe Dr GAUDARD
CHU Nantes - Hôpital Nord Laennec
Nantes
Pitié Salpêtrière Hospital, Intensive Care Unit - Resuscitation
Paris
Pitié-Salpêtrière Hospital, Cardiovascular Surgery Intensive Care Unit
Paris
Hôpital Européen Georges Pompidou
Paris
Hôpital Bichat
Paris
Hôpital Bichat
Paris
CHU Bordeaux - Hôpital cardiologique, GH Sud Pessac
Pessac
NOT_YET_RECRUITING
CHU Rennes, Hôpital Pontchaillou
Rennes
Hôpitaux universitaires de Strasbourg - Hôpital Civil
Strasbourg
COMPLETED
CHU Toulouse - Hôpital de Rangueil
Toulouse
CHU Toulouse - Hôpital de Rangueil
Toulouse
CHRU Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
28.04.2023
Completion date
28.04.2028
Registry ID
NCT05788120
Source
clinicaltrials.gov
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