Reducing Elevated Heart Rate in Patients With Severe Sepsis by by the "Funny Channel" Current (If) Inhibitor Ivabradine
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 主要终点
- mean heart rate
研究概览
简要总结
REHSI is a prospective, multi-center, open label, randomized, controlled two arms, to evaluate the ability of ivabradine to reduce an elevated heart rate in septic shock patients. The primary end point is the reduction of heart rate within 24 hours. This trial will randomize 70 patients (men and women, aged ≥ 18 years) with newly diagnosed Septic Shock (despite adequate fluid resuscitation, were still requiring high-dose norepinephrine (NE) to maintain a mean arterial pressure (MAP) ≥65 mmHg , and had a tachycardia >100 beats per minute (bpm). Treatment period will last 4 days. All patients will be followed for up to six months.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe sepsis due to coronary and non-coronary etiology
- •Severe sepsis diagnosed ≤ 24 h
- •Sinus rhythm with heart rate ≥ 100bpm
- •Written informed consent or identified or suspected positive will with respect to the trial treatment
排除标准
- •Patients who have not yet completed the 18th year of age
- •Pregnancy, lactation
- •Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate <30ml/min
- •severe hepatic insufficiency
- •Sick sinus syndrome
- •Sinu-atrial block
- •pacemaker-dependency 8.3rd degree AV block
- •9.Use of potent cytochrome P450 3A4 inhibitors such as antifungals of the azole -type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see Summary of Product Characteristics (SPC))
研究组 & 干预措施
Ivabradine oral product
Patients in the ivabradine treatment arm receive interventions:an additional enteral preparation (orally, via nasogastric tube or Jejunum tube) of ivabradine for 4 days.
干预措施: Ivabradine Oral Product (Drug)
结局指标
主要结局
mean heart rate
时间窗: 24 hours
the reduction of the mean heart rate of 24 hours after the start of trial treatment
次要结局
- mortality(6 months)
- severity of illness(4 days)
- mean heart rate(4 days)