Role of Ivabradine for Heart Rate Control in Management of Patients With Sepsis and Septic Shock (NCT06742164) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Role of Ivabradine for Heart Rate Control in Management of Patients With Sepsis and Septic Shock
76 participantsStarted 2024-12-30
Plain-language summary
Tachycardia is associated with excess mortality during septic shock. This may be related to the increase in cardiac metabolic demand, impaired cardiac diastolic function and less effect of administered exogenous catecholamines.
In this study, we evaluate the effect of enteral Ivabradine on outcome of septic patients regarding need for vasopressor therapy, mechanical ventilation, renal replacement therapy, length of ICU stay and in-hospital mortality.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with proven or suspected site of infection.
* Patients sepsis (acute organ dysfunction secondary to documented or suspected infection)
* Patients with septic shock (defined as hypotension unresponsive to fluid resuscitation and requiring vasopressor treatment to maintain adequate blood pressure) for at least 6 hours and less than 24 hours.
* Patients with sinus rhythm with heart rate ≥ 95 bpm at time of randomization. Informed consent obtained in accordance with local regulations.
Exclusion Criteria:
* Cardiac arrhythmia, conduction disorder, sinus syndrome ("sick sinus syndrome"), atrial fibrillation and heart block.
* Cardiogenic shock or acute heart failure, without proven or suspected infection.
* Acute coronary syndrome.
* Refractory shock with systolic arterial pressure \<90 mm Hg despite the use of high doses of vasopressors.
* Co-treatment with drugs inducing bradycardia.
* Patients with pacemakers.
* Known pregnancy, breast-feeding, women with of childbearing potential will be tested for pregnancy and excluded if pregnant.
* Known allergy to Ivabradine
* Severe renal failure (creatinine clearance \<15 ml/min) or hepatic failure (prothrombin time \<20%)
* Tachycardia due to hyperthyroidism, pheochromocytoma or severe anemia (\<7 g/dl)
* Enteral feeding impossible.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the percentage of patients with heart rate reduction of at least 10 beats/min