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 range18 Years
SexALL
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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.
What they're measuring
1
the percentage of patients with heart rate reduction of at least 10 beats/min