2024-515019-22-00招募中3 期
A multicenter, prospective, randomized, placebo-controlled, double-blind, multi-arm, multi-stage clinical trial of Ivabradine for heart Rate control In Septic shock [IRISS]
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 429
- 试验地点
- 19
- 主要终点
- There are 2 primary endpoints: i) for treatment selection at interim analysis: the percentage of patients with heart rate within the predefined threshold (80-94 bpm) at hour-48; in case of similar percentages, the percentage of time elapsed within the threshold between inclusion and hour-48 will be considered ii) for the final analysis: 28-day mortality.
研究概览
简要总结
The primary objective is to assess the efficacy of ivabradine in controlling heart rate and improving 28-day survival in patients with septic shock. These objectives will be assessed via a two-stage trial: activity (focused on heart rate control) and efficacy (focused on mortality).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Proven or suspected site of infection
- •Proven or suspected site of infection, - Septic shock (defined as hypotension unresponsive to fluid resuscitation and requiring vasopressor treatment to maintain adequate blood pressure in the context of proven or suspected site of infection) for at least 2 hours and less than 24 hours (inclusion is possible before 2 hours in case of increasing doses of norepinephrine)
- •In sinus rhythm with heart rate ≥ 95 bpm at time of randomization
- •Informed consent obtained in accordance with local regulations
- •Affiliation to a social security regime
排除标准
- •Cardiac arythmia, conduction disorder, sinus syndrome ("sick sinus syndrome"), sino-atrial block; 3rd degree atrioventricular block
- •Severe chronic renal failure (creatinine clearance <15 ml/min) or hepatic failure (prothrombin time <20%)
- •Enteral feeding impossible, vomiting, congenital galactosemia, lactase deficiency, glucose-galactose malabsorption syndrome
- •Tachycardia due to hyperthyroidism, pheochromocytoma or severe anemia (<7 g/dL)
- •Prior enrolment in the trial, participation in another interventional study on septic shock
- •Known legal incapacity (patients under guardianship or curatorship)
- •Decision to limit full care taken before obtaining informed consent
- •Patient under AME (state emergency medical help)
- •Lack of affiliation to social security
- •Cardiogenic shock or unstable or acute heart failure without proven or suspected infection
- •Acute myocardial infarction with angiographic documentation; CCS class ≥ II angina pectoris;
- •Septic shock requiring vasopressor treatment for more than 24 hours
- •Refractory shock with systolic arterial pressure <90 mm Hg) despite the use of high doses of vasopressors (norepinephrine BASE or epinephrine BASE > 2.4 µg/kg/min; these doses should be multiplied by two for noradrenaline salt (tartrate or bitartrate)
- •Co-treatment with drugs inducing bradycardia, QT lengthening or strong inhibition of CYP4503A4, pacemaker, defibrillator, kalemia <3 mM
- •Co-treatment with verapamil or diltiazem (which are moderate CYP4503A4 inhibitors with heart rate reducing properties)
- •Known pregnancy, breast feeding, women with childbearing potential will be tested for pregnancy and excluded if pregnant
- •Known allergy to ivabradine or to any of the excipients, retinitis pigmentosa, congenital galactosemia, lactase deficiency, glucose or galactose malabsorption
结局指标
主要结局
There are 2 primary endpoints: i) for treatment selection at interim analysis: the percentage of patients with heart rate within the predefined threshold (80-94 bpm) at hour-48; in case of similar percentages, the percentage of time elapsed within the threshold between inclusion and hour-48 will be considered ii) for the final analysis: 28-day mortality.
There are 2 primary endpoints: i) for treatment selection at interim analysis: the percentage of patients with heart rate within the predefined threshold (80-94 bpm) at hour-48; in case of similar percentages, the percentage of time elapsed within the threshold between inclusion and hour-48 will be considered ii) for the final analysis: 28-day mortality.
次要结局
- Determine the tolerance of ivabradine
- Evaluate the impact of ivabradine-driven heart rate control on systemic hemodynamics, myocardial stress, organ dysfunction, morbidity, and intensive care mortality
- Determine the pharmacokinetics of ivabradine
研究者
Pr Armand MEKONTSO DESSAP
Scientific
Assistance Publique Hopitaux De Paris
研究点 (19)
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