Effectiveness Of Enteral Ivabradine Plus Standard Therapy Versus Standard Therapy Alone For Heart Rate Control In Patients With Septic Shock : A Single Blind RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- 1. Difference in heart rate between the two groups during the first 96 hours after enrolment
研究概览
简要总结
"Effectiveness of Enteral Ivabradine Plus Standard Therapy Versus Standard Therapy Alone for Heart Rate Control in Patients with Septic Shock: A Single Blind RCT," is designed to evaluate whether the addition of Ivabradine to standard therapy improves heart rate control in patients with septic shock. The study will recruit a total of 234 participants, with 117 in each arm, accounting for a 10% loss to follow-up. Participants will be randomly assigned to receive either Ivabradine plus standard therapy or standard therapy alone. Heart rate will be measured at baseline, 24 hours, 48 hours, 96 hours, and prior to each dose of Ivabradine.
Hypothesis: The study hypothesizes that Ivabradine plus standard therapy will result in superior heart rate control compared to standard therapy alone in patients with septic shock.
The primary outcome of the study is heart rate control at the specified time points. The goal is to determine if Ivabradine more effectively reduces heart rate compared to standard therapy alone in the context of septic shock.
Secondary outcomes include evaluating clinical parameters such as overall hemodynamic stability, requirement of additional vasopressors, duration of mechanical ventilation, ICU length of stay, and mortality rates. These secondary outcomes will provide a broader understanding of Ivabradine’s potential impact on patient outcomes beyond heart rate control, contributing to overall management strategies for septic shock.
The purpose of this study is to explore the potential benefits of Ivabradine in reducing heart rate in septic shock patients, a critical aspect of hemodynamic management. By investigating the effect of Ivabradine in this specific patient population, the trial aims to provide valuable insights that could lead to improved therapeutic strategies for managing septic shock, potentially improving clinical outcomes and patient survival. There is limited evidence. Considering the Indian scenario most studies are observational studies producing conflicting results.
RCT it considered the second evidence in evidence-based medicine, and considering the amount of patients in septic shock, this study is the need of hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Septic shock diagnosed within 24 hours (Patients with heart rate more than 100 beats per minute and requiring noradrenaline support of 0.02-0.4 mcg/kg/min to maintain mean arterial pressure (MAP) above 65 mmHg despite adequate volume resuscitation)
- •Written informed consent.
排除标准
- •Patients less than 18 years or more than 80 years of age.
- •Pre-existing cardiovascular disease (coronary artery disease, congestive heart failure, cardiac rhythm abnormalities, conduction defects, congenital heart disease, or pacemaker in situ, post-cardiac arrest patients).
- •Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate less than 15 mL/min.
- •Severe hepatic insufficiency (Model for End-Stage Liver Disease (MELD) score more than 30, serum bilirubin more than 2.5 times upper limit of normal (ULN), or serum transaminases more than five times ULN).
- •Pregnant or lactating patients.
- •Patients with hemoglobin less than 7 g/dL.
- •Patients with any contraindication to enteral drug administration (including patients with gastrointestinal perforation, mechanical bowel obstruction, or bowel ischemia).
- •Use of potent cytochrome P450 3A4 inhibitors such as azole-type antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin), or HIV protease inhibitors (nelfinavir, ritonavir).
- •Patients with hyperthyroidism.
- •Patients with a baseline heart rate less than 70 beats per minute.
结局指标
主要结局
1. Difference in heart rate between the two groups during the first 96 hours after enrolment
时间窗: Time points for assessing the heart rate are: | 1. At enrolment | 2. At 24 hours | 3. At 48 hours | 4. At 96 hours | These measurements will be recorded over the course of the 18-month trial period.
次要结局
- Effect of IVABRADINE on 14 day Mortality(14 days)
- Effect of Ivabradine on Mean arterial pressure(Time points for assessing)
- Effect of IVABRADINE on 24 hour urine output(24 hours)
- Effect of IVABRADINE on severity of sepsis assessed by following parameters(Serum lactate levels, SOFA score,PaO2/FiO2 , SCvO2,GCS)
- Length of ICU STAY(Total length of ICU stay in days)
- Effect of IVABRADINE on vasopressor ( Noradrenaline dose in mcg/kg/min) use(Time points for assessing are:)
- Effect of IVABRADINE on ejection fraction(Time points for assessing are:)
研究者
Chackappen D Aymanom
All India Institute Of Medical Sciences Rishikesh