Status:
RECRUITING
Ivabradine for Heart Rate Control In Septic Shock
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Septic shock is a major health problem, with several million cases annually worldwide and a mortality approaching 45%. Tachycardia is associated with excess mortality during septic shock. This pejorat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2024
Estimated Enrollment :
429 Patients enrolled
Trial Details
Trial ID
NCT04031573
Start Date
February 24 2021
End Date
December 24 2024
Last Update
June 25 2024
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, France, 94000