Actively Recruiting
Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2026-04-24
172
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor
T
The Third Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Sepsis, a life-threatening syndrome, is often accompanied by tachycardia in spite of adequate volume resuscitation to correct hypovolemia and vasopressor medication to correct hypotension. Recently, relevant studies have shown that sustained tachycardia in sepsis was also related to high mortality, and appropriate control of heart rate could improve prognosis. Ivabradine reduces heart rate directly without a negative inotropic effect through inhibition of the If ionic current，which is absent from the traditional rate control drug (beta-blockers). This is a prospective, multicenter, randomized, open label study designed to compare ivabradine with placebo on the difference of heart rate and haemodynamics in patients with sepsis.
CONDITIONS
Official Title
Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or above
- Currently treated in an intensive care unit
- Diagnosed with sepsis according to Sepsis-3.0 criteria, including use of antimicrobial agents and acute SOFA score increase of at least 2 points
- Mean arterial pressure maintained at 65 mmHg or higher with adequate volume resuscitation and vasopressor therapy
- Hemodynamics stable with consistent vasopressor dosage for at least 2 hours
- Sinus rhythm with heart rate of 95 bpm or higher maintained for at least 2 hours but less than 72 hours
You will not qualify if you...
- Previous ivabradine therapy or known allergy to ivabradine
- Severe liver dysfunction (Child-C grade)
- Chronic renal failure with glomerular filtration rate less than 15 ml/min/1.73 m2, except if on continuous renal replacement therapy
- History of seizure disorder
- Contraindications to gastrointestinal drug administration
- Pregnant or breastfeeding
- Use of strong CYP3A4 inhibitors such as certain antifungals, macrolide antibiotics, or HIV protease inhibitors
- Active bleeding
- Non-septic cardiac dysfunction including recent acute myocardial infarction, chronic heart failure (NYHA Class III), congenital heart disease, pericardial tamponade, severe aortic regurgitation, or aortic coarctation
- Sinoatrial block, sick sinus syndrome, atrioventricular block, or pacemaker-dependent heart rate
- Refractory shock despite active treatment with specific criteria lasting more than 5 hours
- Beta blocker use within 24 hours before enrollment
- Pheochromocytoma
- Recent cardiopulmonary resuscitation
- Participation in another interventional clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
the Affiliated Panyu central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
2
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
3
the Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
Actively Recruiting
Research Team
Z
Zhenhui Zhang, PhD
CONTACT
W
Weiyan Chen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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