Impact of Perioperative Levosimendan on Patients Undergoing Cardiac Surgery With Low Ejection Fraction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- death through day 30,
研究概览
简要总结
to compar levosemindan to other cardiac intropic medications that strengthen the heart in diffrent common adult heart surgery with patients with low ejection fraction(weak heart)
详细描述
in this study show the effect of levosemindan use during coronary artery surgery ,heart valve surgery and combined coronary and valve surgery in comparison to other traditional medications with patients with low ejection fraction(weak heart)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Valve surgery
- •CABG surgery,
- •combined surgery
- •all patients Ejection Fraction less than 35 ٪ -
排除标准
- •Patients age ≤ 20-70 < years
- •Aortic and redo surgery
- •any patients with Ejection Fraction more than 35 ٪ -
研究组 & 干预措施
traditional
this group of patients will recieve traditional intropic drugs
干预措施: adrenaline,noreadrenaline,dopamine and doputamine (Drug)
levosemindan
this group of patients will recieve levosemindan
干预措施: levosemindan (Drug)
结局指标
主要结局
death through day 30,
时间窗: 1 month (no scale for measurement as death may occured due to multible causes that be difficult to be identified and measured )
death occured either intraoperative , ICU, ward or after discharge to home within month of the day of the surgery
Renal-replacement therapy
时间窗: 1 month
included haemodialysis, peritoneal dialysis, or continuous Veno venous haemodialysis(indicated when serum creatinine above 2.0 mg/dl or an increase of 50% above baseline value)
Perioperative myocardial infarction
时间窗: 5 days
defined as a creatine kinase MB level of more than 100 ng per millilitre or a level that was more than 10 times the upper limit of the normal range specified at the local laboratory, regardless of changes on the electrocardiogram, or a creatine kinase MB level that was more than 50 ng per millilitre or a level that was more than 5 times the upper limit of the normal range with new Q waves that were more than 30 msec in duration in two contiguous leads or new left bundle-branch block
Intra Aortic Ballon Pumb insertion
时间窗: 5 days(no scale for measurement )
it consisidered to be one of the ventricular assissted device that need to be inserted in post cardiac surgery shocked patiients that not respond heamdynamically to highest doses of cardiac intropes
次要结局
未报告次要终点
研究者
Mohamed Ibrahim Mohamed El Anwar
assis professor
Zagazig University