About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Ivabradine 5mg Tab
DrugIvabradine (5 mg twice daily) orally or via nasogastric tube
control
DrugPatients didn't receive Ivabradine .
Treatment groups
Trial outcomes
Primary outcomes
the percentage of patients with heart rate reduction of at least 10 beats/min
Secondary outcomes
Mean heart rate
Mean arterial blood pressure
percentage of patients needed vasopressor
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: