Feasibility of Transepicardial Atrial Injection of Saline at the Time Open Chest Cardiac Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Recruitment uptake
研究概览
简要总结
Single blind feasibility trial using a binary 'traffic light' design to evaluate the feasibility of injecting normal physiological saline into the atria of patients at the time of clinically indicated open chest cardiac surgery.
详细描述
In this project, The investigators will see if patients can undergo successful transepicardial injection of saline at the time of cardiac surgery as compared to no injection. Patients will be randomised in a 1:1 allocation ratio using a parallel two-arm design. The study is designed to meet the following 3 feasibility objectives before proceeding: reasonable recruitment uptake, successful transepicardial injection of saline into the atria, and adequate retention of patients at follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Undergoing non-emergent open chest cardiac surgery for coronary artery bypass graft (CABG) and/or valve disease.
排除标准
- •Age less than or equal to 18 years of age.
- •Pregnant or breast feeding.
- •Patient is unable or unwilling to provide informed consent.
- •Patient is included in another randomized clinical trial.
- •A history of complex congenital heart disease.
- •Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years.
- •Underwent ineligible procedures during or prior to operation (including atrial fibrillation ablation, heart transplantation, pulmonary thromboendarterectomy, isolated thoracic aorta procedures, ventricular assist device insertion, extracorporeal membrane oxygenator insertion, and percutaneous valve replacement).
- •Patients for whom the investigator believes that the trial is not in the interest of the patient.
研究组 & 干预措施
saline injection
After the patient is placed on cardiopulmonary bypass, the surgeon will inject a saline into the atria.
干预措施: normal saline (Drug)
结局指标
主要结局
Recruitment uptake
时间窗: 1 year
Recruitment uptake \<20% (project not feasible), 20-35% (protocol needs to be revised), and \> 35% (project feasible).
Treatment fidelity
时间窗: 1 year
Treatment successfully applied \< 50% (approach not feasible), 50-75% (approach needs to be revised) and \> 75% (approach is feasible).
Participant retention (follow up)
时间窗: 30 days post surgery
Follow up: \< 65% (project not feasible), 65-85% (follow-up needs to be revised), \> 85% (project is feasible).
次要结局
未报告次要终点