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临床试验/NCT04193813
NCT04193813已完成不适用

Predictors of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Prospective Cohort Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2018年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
123
试验地点
1
主要终点
Incidence of POAF

研究概览

简要总结

There are a wide range of significant epidemiological, clinical, and operative predictors for the development of post-CABG AF including older age, female gender, large LA diameter, higher CHA2DS2-VASc score, valve replacement and postoperative inotropic support. Nevertheless, further large-scale studies are still needed to confirm our findings

详细描述

We included patients undergoing isolated CABG or CABG with (Aortic and / or Mitral) valve replacement with an age group between 18 and 70 years old.

Patients diagnosed preoperatively with AF or have history of AF, patients with history of existing pre-operative rhythm other than normal sinus rhythm (NSR), patients with impaired systolic function (Ejection fraction (EF) < 30%), patients with end stage renal disease (ESRD) on hemodialysis and patients who refused to participate in the study were excluded from the study.

Sample Size and Sampling: Using PASS program, setting alpha error at 5% and power 80%. Results from previous study Ducceschi et al. (6) showed that left atrial (LA) diameter was an independent factor affecting AF post CABG. Based on this, the needed sample was 123 cases undergoing CABG, including at least 24 patients with dilated LA.

All individuals were monitored for AF during the postoperative ICU stay with continuous ECG (5-leads) monitor, daily 12-lead ECG recording to confirm an episode of AF. AF was considered if P wave was absent before the QRS complex together with irregular ventricular rhythm on the rhythm strips.

Only AF episodes lasting > 5 minutes were counted. In the present study, the following data, as potential predictors of POAF, was collected from every eligible participant; age, sex, smoking and left atrial (LA) diameter based on formal preoperative Trans-thoracic Echocardiography. Serum potassium (K+) level was routinely measured postoperatively on ICU admission and every 2 hours and on demand (if arrhythmia occurs or suspected abnormal potassium level). It was recorded for statistical analysis on admission and every 12 hours and on demand until the patient was discharged.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing isolated CABG
  • Patients undergoing CABG with (Aortic and / or Mitral) valve replacement
  • age group between 18 and 70 years old.

排除标准

  • Patients diagnosed preoperatively with AF or have history of AF
  • Patients with history of existing pre-operative rhythm other than normal sinus rhythm (NSR)
  • Patients with impaired systolic function (Ejection fraction (EF) < 30%)
  • Patients with end stage renal disease (ESRD) on hemodialysis
  • Patients who refused to participate in the study

结局指标

主要结局

Incidence of POAF

时间窗: 6 months

Incidence of POAF 72hours postoperative

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hanaa Mohamed Abdallah ElGendy MD

Assistant Professor

Ain Shams University

研究点 (1)

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