NCT01022983撤回4 期
Preoperative Levosimendan in Patients With Heart Failure Undergoing Elective Noncardiac Surgery: A Randomized, Placebocontrolled Trial. SIMPLE Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Heartfailure - Highest NT-proBNP-value the first 7 days after surgery
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute surgery. Hip Fracture
- •Patient with cardiac failure (EF < 35%) or known coronary disease
- •At least 2 of 11 comorbidities
- •Patient has to use at least one heart failure medication
- •Symptoms of heart failure
- •NT-proBNP > 2000pg/ml
排除标准
- •< 18 years old
- •Participants in other pharmacological study
- •Abuse of medicaments or alcohol
- •Pregnant or breastfeeding women
- •AMI at admission
- •Serious aortic stenosis (< 1 cm2)
- •Sustained ventricular tachycardia
- •Earlier episodes of "torsades de pointes"
- •Sustained heartbeat > 120/minute
- •Systolic BP < 90 mmHg
- •Surgery planned not before 2 hours of study medication can be infused preoperative
- •Cardiac surgery
- •S-K < 3 mmol/l
- •Allergy levosimendan
- •Serious liver failure (Known Class C Child-Pugh score)
- •Serious kidney failure (GFR < 30 ml/min.)
- •Prolonged QTc-interval (male QTc > 0,43 s, female QTc > 0,45 s)
研究组 & 干预措施
Levosimendan
Active Comparator
干预措施: Levosimendan (Drug)
Povidon, waterfree etanol, glucosis 5%
Placebo Comparator
干预措施: Levosimendan (Drug)
Povidon, waterfree etanol, glucosis 5%
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Heartfailure - Highest NT-proBNP-value the first 7 days after surgery
时间窗: NT-proBNP 6 hours postoperative, 24 hours postoperative, 48 h postoperative, 72 h postoperative, 96 h postoperative, 120 h postoperative, 144 h postoperative and 168 h postoperative
次要结局
- Days of hospitalization(Hospital stay - number of days patients are hospitalized)
- Use of inotropes (dopamine, Norepinephrine)during postoperative unit stay. Mg/microgram(After 16-18 hours, after 48 hours and every 24 hours if still in the PO-Unit)
- Mortality(30 days)
- Ischemia(7 days postoperative)
- Myocardial necrosis(7 days postoperative)
研究者
Espen Lindholm
Seksjonsoverlege
Sykehuset i Vestfold HF
研究点 (4)
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