Risk Factors of Atrial Fibrillation After Cardiac Surgery (PFAS)
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Mickael LESCROART
- 电话号码:+33387186632
- 邮箱:mickael.lescroart@chr-metz-thionville.fr
研究联系人备份
- 姓名:Andreia CARVALHO DE FREITAS
- 电话号码:+33387553323
- 邮箱:projet-recherche-clinique@chr-metz-thionville.fr
学习地点
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Metz、法国、57085
- CHR Metz-Thionville Hopital de Mercy
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Occurrence of postoperative atrial fibrillation
大体时间:from cardiac surgery (day 0) up to ICU discharge (about 3 days on average)
|
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)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2026-03-Obs-CHRMT
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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