MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Postoperative morbi-mortality
研究概览
简要总结
The purpose of this study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting
详细描述
Depression is known to have an adverse effect on post-operative mortality and morbidity after coronary artery bypass grafting. Cardiac surgery is known to cause transient depression in patients. The purpose of this double-blind, randomized study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting. Treatment is given from 21 to 15 days pre-operatively until the 6th post-operative month. Morbidity as defined by the STS database as well as mortality is checked during 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective coronary artery bypass surgery
- •> 30 years old
排除标准
- •Contra-indication to antidepressive treatment
- •Already treated by antidepressive treatment
- •Concomitant cardiac surgery as valve replacement etc.
- •Patients having anticoagulation therapy
- •Pregnant women
- •Hepatic insufficiency
研究组 & 干预措施
Treatment
Escitalopram given
干预措施: Escitalopram (Drug)
Placebo
Placebo given
干预措施: Escitalopram (Drug)
结局指标
主要结局
Postoperative morbi-mortality
时间窗: 6 months and 1 year
(1) cardiac : (2) pulmonary (3) neurologic (4) renal (5) rythm (6) infectious(7) any surgery or invasive procedure necessary to treat a postoperative adverse event associated with the initial cardiac surgery ; (8) myocardial infarction during follow-up; (9) congestive heart failure during follow-up; (10) rehospitalization for cardiac related cause, and (11) rehospitalization for non-cardiac related cause
次要结局
- Quality of life measured by SF-36(preoperatively and 1,3,6, and 12 months post-operatively)
- Beck depression index (BDI) and Center for Epidemiologic Studies Depression (CES-D) Scale(preoperatively, and 1,3,6, and 12 months post-operatively.)
研究者
Prof. Sidney Chocron
MD,PhD
Hopital Jean Minjoz