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临床试验/NCT06553391
NCT06553391已完成不适用

Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis

Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
1
主要终点
Sinus rhythm

研究概览

简要总结

The goal of this observational study is to learn about the lthe effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF. The main question it aims to answer is:

Does the regimen improve the success rate of cardioversion in patients with persistent AF during cardiac surgery? The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol.

This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from August 1, 2024, to January 1, 2025. Patients diagnosed with atrial fibrillation who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study.

详细描述

Background: Most patients with atrial fibrillation (AF) continue to experience AF following cardiac surgery, which is not conducive to postoperative circulatory stability. Intraoperative active cardioversion has rarely studied due to uncertainty regarding the efficacy of pharmacological cardioversion and the recurrence rate of AF in patients with persistent AF.

Objective

To assess the effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF.

Methods: This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from August 1, 2024, to January 1, 2025. Patients diagnosed with AF who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study. These patients undergoing pharmacological cardioversion during surgery were matched with untreated patients in a 1:1 ratio based on age, sex, weight, diagnosis, beta blocker and digoxin usage, indicators from cardiac ultrasound and blood gas analysis. The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol. The choice between these drugs depends on the patient's blood pressure and heart rate. The incidence of cardioversion in patients who underwent the tetralogy of medication regimen approach was compared with that of untreated patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Aged 18-70 years,
  • Who were scheduled for elective cardiac surgery under general anesthesia,
  • Who were diagnosed with atrial fibrillation by preoperative 12-lead electrocardiogram or 24-hour holter electrocardiogram.

排除标准

  • Allergic to iodine, amiodarone or its excipients
  • Pulmonary fibrosis
  • Keratopathy or severe loss of vision or blindness
  • Patients with sick sinus syndrome, severe bradycardia (heart rate <50bpm), second- or higher-degree atrioventricular block
  • Preoperative intravenous infusion of amiodarone
  • Intraoperative radiofrequency ablation of atrial fibrillation
  • The patient is participating in another interventional clinical study.

研究组 & 干预措施

TMR group

The treatment regimen for the tetralogy of medication regimen group (TMR group)commences with the administration of amiodarone during rewarming. In the event of cardiac relapse, a combination of the following drugs may be utilized: aminophylline, ephedrine, and isoproterenol. The selection of these medications is contingent upon the patient's blood pressure and heart rate.

干预措施: The tetralogy of medication regimen (Drug)

结局指标

主要结局

Sinus rhythm

时间窗: From the release of the aortic cross-clamp until 12 hours after surgery

Electrocardiogram monitoring

次要结局

  • Mean arterial pressure(From the release of the aortic cross-clamp until the end of surgery)
  • the use of temporary pacemakers(From the release of the aortic cross-clamp until 12 hours after surgery)

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Linlin

Clinical Professor

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (1)

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