A Pilot, Randomised Controlled Study of Ivabradine for Heart Rate Reduction in Critically Ill Patients with Septic Shock

A Pilot, Randomised Controlled Study to evaluate whether the administration of enteral Ivabradine plus standard care reduces tachycardia in critically ill adult patients with septic shock compared to standard care alone.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001675213

Enrollment

Registered

2018-10-11

Start date

2018-11-30

Completion date

2019-06-03

Last updated

2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Septic shock is a state of low blood pressure resulting from a physiological response to an infection. The low blood pressure commonly presents along with an elevated heart rate, which is in turn associated with poor outcomes in patients. Beta blockers have had favourable effects in the past, but its use in this clinical context may potentially lead to an exacerbation of the low blood pressure. Ivabradine causes selective heart rate reduction via an alternative pathway and is not known to have any other effects on the heart. It has previously been shown to have benefit in the treatment of chronic heart failure and stable cardiac disease, and previous studies have documented safety and tolerability. Furthermore, it has been used in acute medicine for the treat-ment of patients with low blood pressure due to acute heart failure and is currently being tested in critically ill patients with multi-organ failure. We propose to conduct a feasibility study to test whether Ivabradine can be used safely to reduce the heart rate in patients who are in septic shock with an elevated heart rate.

Interventions

Enteral ivabradine 5mg twice daily in addition to standard care. Study treatment will be given for a total of 120 hours (5 days) or until the patient is discharged from ICU (whichever occurs first). In the event of bradycardia with a HR of <50 or in the presence of symptomatic bradycardia or in the event of AF or any visual disturbance, Ivabra-dine will be discontinued. These data will be included in the final manuscript of the study.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Patients aged equal and/or older than18 years • Septic shock as defined as o Hypotension (mean arterial pressure < 65 mmHg) not respon-sive to fluid resuscitation o Requirements for vasopressors (noradrenaline, vasopressin, metaraminol, phenylephrine) o Infection of any source • Sinus tachycardia with heart rate equal or greater than 100

Exclusion criteria

Exclusion criteria • Acute heart failure as defined by the presence of cardiogenic shock or cardiogenic pulmonary edema • Arrhythmmias include Atrial fibrillation (AF) • Acute hepatic failure as defined by the development of severe acute liver injury with encephalopathy and impaired synthetic function (INR equal or greater than 1.5) in a patient with no pre-existing liver disease • Decompensated chronic liver disease as defined by the presence of jaundice, ascites, variceal haemorrhage or hepatic encephalopathy in a patient with known liver cirrhosis • Physician preference • If the patient expected to die during this admission • Pregnancy

Outcome results