Prophylaxis for Patients at Risk to Eliminate Post-operative Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Knowledge of which patients received intervention and placebo
研究概览
简要总结
After surgery on the lungs or esophagus, 12-46% of patients experience an irregular heart rhythm called atrial fibrillation. Although usually transient, post-operative atrial fibrillation is associated with longer stay in hospital, greater complications, and increased risk of death. Several medications have been shown to be effective at reducing the risk of atrial fibrillation after their surgery with the greatest effectiveness and safety demonstrated with amiodarone. Nevertheless, amiodarone has potential side effects, and so it is only recommended in patients with increased risk of developing atrial fibrillation. A tool has been developed and validated to identify high-risk patients but no clinical trial has looked at the effectiveness of administering amiodarone in this high-risk group. This study aims to assess the feasibility and safety of conducting a clinical trial where patients are randomized to receive amiodarone or placebo. This is critical before considering a full-scale trial to assess the effectiveness of amiodarone in reducing atrial fibrillation after surgery on the lungs or esophagus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or greater
- •Undergoing major non-cardiac pulmonary or esophageal surgery (including esophagectomy, pulmonary wedge resection, lobar resection, pneumonectomy, or gastrectomy)
- •POAF prediction score greater than or equal to 4
排除标准
- •Aged less than 18 years
- •History of atrial arrhythmia (paroxysmal or persistent), or Wolf-Parkinson-White syndrome (WPW), or 2nd or 3rd degree heart block without a pacemaker
- •Current antiarrythmic therapy (including amiodarone, propafenone, sotalol, flecainide, and dronedarone)
- •Previous severe adverse reaction or contraindication to amiodarone (including pre-existing interstitial lung disease, or history of hepatotoxicity from amiodarone)
- •QTc interval longer than 450ms
- •Serum alanine transaminase or aspartate transaminase over 3 times the upper limit of normal, or Child-Pugh class C
- •Allergy to amiodarone
研究组 & 干预措施
Intervention Arm
Patients randomized to amiodarone treatment
干预措施: Amiodarone (Drug)
Control Arm
Patients randomized to placebo treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Knowledge of which patients received intervention and placebo
时间窗: Upon study completion, 1 year following study initiation
Feasibility of blinding of participant, care provider, investigator, and outcomes assessor to the intervention allocation of participants will be evaluated by administering a survey to assess their knowledge of which patients received the intervention and placebo
Intervention delivery
时间窗: Upon study completion, 1 year following study initiation
Intervention delivery will be assessed by determining if protocol adherence rates exceed \>90% and recording observational data on the quality of intervention delivery using a data collection sheet
Adherence to safety protocol
时间窗: Upon study completion, 1 year following study initiation
Monitoring of safety will be assessed by determining the rate and efficiency of reporting adverse events if they occur and monitoring adherence rates to safety and monitoring protocols
Resources
时间窗: Upon study completion, 1 year following study initiation
Resources required to conduct a future multi-centre PREP-AF trial will be assessed by evaluating the administrative capacity of the POAF research team, including the required number of hours of research assistant time, as well as the feasibility of the designated study budget
Capability for enrolment
时间窗: Upon study completion, 1 year following study initiation
Capacity for enrolment will be assessed, in order to determine recruitment potential and an optimal sample size estimated for a full-scale RCT, by measuring the following outcomes: proportion of patients risk stratified and screened, proportion of eligible individuals consenting to involvement in the study, proportion of recruited individuals who are enrolled in the study.
Proportion of patients randomized who receive the intervention
时间窗: Upon study completion, 1 year following study initiation
Feasibility of the randomization process will be evaluated including the proportion of patients randomized who receive the intervention
Protocol compliance
时间窗: Upon study completion, 1 year following study initiation
Monitoring of protocol compliance will be measured by the frequency, rate, and rationale of events when study activities diverge from the REB-approved protocol
Proportion of patients for which data could be abstracted
时间窗: Upon study completion, 1 year following study initiation
Feasibility of data extraction analysis will be evaluated by the proportion of patients for which the required data could be abstracted: medication use, incidence of post-operative atrial fibrillation, post-operative outcomes, etc.
次要结局
- Incidence of postoperative atrial fibrillation(Within 30 days post-surgery)
- Hospital length of stay(Within 30 days post-surgery)
- Severity of postoperative atrial fibrillation(Within 30 days post-surgery)
- Other postoperative complications(Within 30 days post-surgery)