Ivabradine in Sepsis for Heart Rate, Benefits and Disadvantages trial (IS-HR-BAD)

A/Prof Andrew Udy,0 个研究点目标入组 20 人开始时间: 2016年7月15日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1.Age greater than or equal to 18 years of age;
•2.Presumed diagnosis of sepsis on intravenous antibiotics;
•3.A heart rate of >100/min in sinus rhythm;
•4.The requirement for vasopressor infusion to maintain a mean arterial pressure > 65mmHg despite adequate fluid resuscitation (defined by a central venous pressure > 8mmHg);
•5.Informed consent is obtained from the patient or surrogate decision maker;
•6.The patient is anticipated to require ICU care beyond the next calendar day; and
•7.Presence of an indwelling urinary catheter (IDC) and arterial line

•1.Pacemaker in situ; or
•2.Use of a beta blocker within the last 48 hours; or
•3.History of rhythm disturbance or bradycardia; or
•4.Concurrent use of inhibitors of CYP3A4 (macrolide antibiotics, azole antifungals) that interact with the metabolism of ivabradine; or
•5.Inability to administer enteral medication; or
•6.Severe hepatic dysfunction – defined as an AST or ALT > 5 x upper limit of normal (ULN), or and AST or ALT > 3 x ULN with an associated total bilirubin > 2 x ULN; or
•7.Pregnancy; or
•8.Breast-feeding mothers; or
•9.Inability to complete the monitoring period in ICU following ivabradine administration; or
•10.Patient not expected to survive next 24-48 hours and/or clinician not committed to ongoing life support

发起方

A/Prof Andrew Udy,