- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07625033
Risk Factors of Atrial Fibrillation After Cardiac Surgery (PFAS)
Descripción general del estudio
Estado
Condiciones
- Bypass de la arteria coronaria
- Cirugía cardíaca
- Bypass cardiopulmonar
- Anestesia
- Cirugía Torácica
- Cuidado Postoperatorio
- Unidad de Cuidados Intensivos
- Recuperación mejorada después de la cirugía
- Medicina perioperatoria
- Atención preoperatoria
- Reemplazo de válvula aórtica
- Implantación de prótesis de válvula cardíaca
- Anestesia cardiaca
- Atención intraoperatoria
- Peri Operative Medicine
Descripción detallada
STUDY OBJECTIVE
The aim of this study is to compare atrial fibrillation incidence between patients having undergone a cardiac surgery with a stellate ganglion block and patients having undergone a cardiac surgery without a stellate ganglion block .
STUDY PROCEDURES
This study does not require any additional examinations or specific treatments. It uses information already routinely available in the CHR Mercy electronic medical record systems (Diane, Metavision, dxCare).
This is a prospective single-center study. Patients referred for cardiac surgery (both off-pump and on-pump procedures) will be included for data collection between June 2026 and June 2029. The use of a stellate ganglion block after a cardiac surgery is a routine practice in our hospital that varies depending on the intensivist and/or the time period.
Clinical, demographic, and biological data will be collected in patient records. Perioperative data related to the surgical procedure will also be collected, as well as data regarding the management and clinical course during the intensive care unit stay.
The socio-demographic data collected as part of routine clinical care will include: age, sex, past medical and surgical history, chronic medications, type of cardiac disease, coronary angiography findings, history of coronary stenting, stent localization, preoperative assessment (lower limb Doppler ultrasound, carotid Doppler ultrasound), type of coronary artery bypass surgery (off-pump/on-pump), and history of cardiac arrhythmias.
The following clinical data, routinely collected on a daily basis as part of standard care, will be recorded: blood pressure, heart rate, body temperature, respiratory rate, duration of mechanical ventilation, daily urine output (mL), FiO2 (for intubated patients, otherwise oxygen flow rate), need for non-invasive ventilation (Yes/No) assessed daily, mobilization to chair (Yes/No), presence of clinical Claude Bernard-Horner syndrome, recurrent laryngeal nerve palsy, swallowing disorders/aspiration events, inflammatory signs around the perineural catheter, pain at the puncture site/cervical region, chest pain assessed using a visual analogue scale (VAS), signs of phrenic nerve paralysis (reduced thoracic expansion on the stellate block side), acute neurological disorders (confusion, agitation, seizures), daily chest drain output, number and location of chest drains, type and dosage of inotropic support (dobutamine, levosimendan), type and dosage of vasopressors (norepinephrine, vasopressin).
The following paraclinical data will be monitored daily: ECG recordings (D1, D2, D3, D4), continuous ECG Holter monitoring, chest X-ray on D0 as part of routine care, and transthoracic echocardiography (TTE) performed routinely on D1, D2, D3, and D4, including: left ventricular outflow tract velocity-time integral (LVOT VTI), heart rate, LVOT area (cardiac output/cardiac index calculation), E-wave velocity (cm/s), A-wave velocity (cm/s), mitral E' velocity (cm/s), TAPSE (mm), tricuspid S-wave velocity (cm/s), pericardial effusion (Yes/No), inferior vena cava diameter (mm), aortic regurgitation grade (1-4), mitral regurgitation grade (1-4), maximum intraventricular gradient (mmHg), and mean transvalvular gradient (mmHg).
Biological data collected as part of routine care
Day 0 (D0)
Serum electrolytes (sodium, potassium), renal function tests (serum creatinine, urea), liver function tests (AST, ALT, gamma-GT, alkaline phosphatase, total bilirubin, conjugated bilirubin), troponin, NT-proBNP, CPK, complete blood count, PT, aPTT, fibrinogen, and serum bicarbonate levels.
Day 1 (D1) (and all consecutive days in ICU)
Serum electrolytes (sodium, potassium), renal function tests (serum creatinine, urea), liver function tests (AST, ALT, gamma-GT, alkaline phosphatase, total bilirubin, conjugated bilirubin), troponin, NT-proBNP, CPK, complete blood count, PT, aPTT, fibrinogen, serum bicarbonates, plus venous blood gas analysis (pH, lactate, PaO2, PaCO2, bicarbonates, ScvO2) and arterial blood gas analysis (pH, lactate, PaO2, PaCO2, bicarbonates, SaO2, PaO2/FiO2 ratio).
Those biological data will be monitored as long as the patient is in ICU.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mickael LESCROART
- Número de teléfono: +33387186632
- Correo electrónico: mickael.lescroart@chr-metz-thionville.fr
Copia de seguridad de contactos de estudio
- Nombre: Andreia CARVALHO DE FREITAS
- Número de teléfono: +33387553323
- Correo electrónico: projet-recherche-clinique@chr-metz-thionville.fr
Ubicaciones de estudio
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Metz, Francia, 57085
- CHR Metz-Thionville Hopital de Mercy
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- age >18
- having undergone a scheduled cardiac surgery in the study center
- having agreed to the reuse of their hospital care data
Exclusion Criteria:
- Atrial fibrillation at the admission in hospital.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Occurrence of postoperative atrial fibrillation
Periodo de tiempo: from cardiac surgery (day 0) up to ICU discharge (about 3 days on average)
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monitor on cardiac ECG monitoring performed during the routine cares in cardiac ICU
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from cardiac surgery (day 0) up to ICU discharge (about 3 days on average)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-03-Obs-CHRMT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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