A Phase II Feasibility study to determine the efficacy and dose-response of a single enteral dose of Ivabradine to reduce participant heart rate in patients admitted to the intensive care unit with sepsis and sinus tachycardia

Phase 2

Recruiting

• Conditions: Sepsis; tachycardia; Infection - Other infectious diseases; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12616000940471
• Lead Sponsor: A/Prof Andrew Udy,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate, assessed by continuous ECG monitoring with supplimentary confirmation from pulse oximetry, arterial line and Vigileo.[Continuously monitored with hourly timepoints for data collection from time of ivabradine administration to 12 hours post administration]