Clinical effect of lowering heart rate in sepsis syndromes; comparing ivabradine 10 mg and 15 mg versus placebo.

Not Applicable

Recruiting

• Conditions: Circulatory System; sepsis syndromes

• Registration Number: PACTR201510001274643
• Lead Sponsor: anesthesia and ICU departement , faculty of medicine, Cairo univ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

severe sepsis, septic shock or Multiple organ dysfunction syndrome
-Sinus rhythm with heart rate ¿ 90bpm

Exclusion Criteria

refusal by the patient or the responsible guardian
¿Patients younger than 18 years of age
¿Hypersensitivity to the active substance or any of the excipients
¿Pregnancy, lactation
¿Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate <30ml/min
¿Patients with malignant hyperthermia or burn patients
¿Patients with acute rejection after organ transplantation
¿Patients who have participated or participate in other studies within the last 3 months
¿Other types of shock than septic or cardiogenic shock
¿Patients with severe valvular heart disease
¿Severe hepatic insufficiency
¿Sick sinus syndrome
¿pacemaker-dependency
¿3rd degree AV block
¿Use of potent cytochrome P450 3A4 inhibitors such as antifungals of the azole -type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reduction in base line heart rate,