Ivabradine for Heart Rate Control In Septic Shock

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 23, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the use of Ivabradine as a treatment to help control heart rate in patients experiencing septic shock. Septic shock is a serious condition that occurs when the body has a severe infection leading to dangerously low blood pressure and other complications. The trial aims to see if Ivabradine can effectively lower heart rates without causing harmful side effects, helping to improve heart function and potentially reducing the risk of complications during this critical time.

To participate in the trial, candidates must be 18 years or older and have septic shock that has lasted between 2 and 24 hours. They should also be in a normal heart rhythm with a heart rate of 95 beats per minute or higher. Participants can expect to receive the study treatment and will be closely monitored throughout the trial. It's important to note that certain conditions, such as specific heart problems or severe kidney issues, may exclude individuals from participating. By joining this study, participants may contribute to valuable research that could improve treatment options for others facing septic shock in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older,
• • 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.
• Exclusion Criteria:
• • Age \< 18 years,
• • Cardiac arythmia, conduction disorder, sinus syndrome ("sick sinus syndrome"), sino-atrial block; 3rd degree atrioventricular block, "IRISS" protocol, version 6.0 of 30/10/2023 7/47 This document is the property of DRCD / APHP. All reproduction is strictly prohibited.
• • 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,
• • 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.