NCT06742164尚未招募不适用
Role of Ivabradine for Heart Rate Control in Management of Patients With Sepsis and Septic Shock
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- the percentage of patients with heart rate reduction of at least 10 beats/min
研究概览
简要总结
Tachycardia is associated with excess mortality during septic shock. This may be related to the increase in cardiac metabolic demand, impaired cardiac diastolic function and less effect of administered exogenous catecholamines.
In this study, we evaluate the effect of enteral Ivabradine on outcome of septic patients regarding need for vasopressor therapy, mechanical ventilation, renal replacement therapy, length of ICU stay and in-hospital mortality.
详细描述
All patients will be subjected to:
- Thorough history taking:
- Demographic data: age, sex and residence.
- Clinical presentation (fever, hypotension , tachycardia , tachypnea and anuria) .
- Family history of immunodeficiency disease
- History of recurrent
- Clinical examination:
- Vital signs: heart rate (HR) , blood pressure (BP), and temperature.
- Abdominal examination .
- Detect septic focus .
- Urine out put .
- Follow up until discharge from ICU.
- Laboratory investigations:
All patient will be screened with :
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
- •Patients with proven or suspected site of infection.
- •Patients sepsis (acute organ dysfunction secondary to documented or suspected infection)
- •Patients with septic shock (defined as hypotension unresponsive to fluid resuscitation and requiring vasopressor treatment to maintain adequate blood pressure) for at least 6 hours and less than 24 hours.
- •Patients with sinus rhythm with heart rate ≥ 95 bpm at time of randomization. Informed consent obtained in accordance with local regulations.
排除标准
- •Cardiac arrhythmia, conduction disorder, sinus syndrome ("sick sinus syndrome"), atrial fibrillation and heart block.
- •Cardiogenic shock or acute heart failure, without proven or suspected infection.
- •Acute coronary syndrome.
- •Refractory shock with systolic arterial pressure <90 mm Hg despite the use of high doses of vasopressors.
- •Co-treatment with drugs inducing bradycardia.
- •Patients with pacemakers.
- •Known pregnancy, breast-feeding, women with of childbearing potential will be tested for pregnancy and excluded if pregnant.
- •Known allergy to Ivabradine
- •Severe renal failure (creatinine clearance <15 ml/min) or hepatic failure (prothrombin time <20%)
- •Tachycardia due to hyperthyroidism, pheochromocytoma or severe anemia (<7 g/dl)
- •Enteral feeding impossible.
研究组 & 干预措施
Patients received Ivabradine
Active Comparator
干预措施: Ivabradine 5mg Tab (Drug)
Patients didn't receive Ivabradine .
Sham Comparator
干预措施: control (Drug)
结局指标
主要结局
the percentage of patients with heart rate reduction of at least 10 beats/min
时间窗: after 72 hours of treatment
次要结局
- Mean heart rate(72 hours of treatment)
- Mean arterial blood pressure(72 hours of treatment)
- percentage of patients needed vasopressor(72 hours of treatment)
研究者
RAMY AHMED
Assistant Professor of Anesthesia
Ain Shams University
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