Effect of heart rate control with ivabradine on hemodynamic in patients with sepsis: study protocol for a prospective, multicenter, randomized controlled trial.
Jiezhao Zheng, Deliang Wen, Zelin Pan...
https://pubmed.ncbi.nlm.nih.gov/39443954Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID05882708
Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis: a Prospective, Multicenter, Randomized Controlled Trial
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2026-04-24
172
Participants Needed
3
Research Sites
21 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
Researchers are investigating the effect of controlling heart rate with ivabradine in adult patients with sepsis who experience sustained fast heart rates despite adequate treatment. Sepsis is a serious condition often accompanied by rapid heartbeats that can worsen outcomes. This prospective, multicenter, randomized, open-label study aims to evaluate the safety, feasibility, and impact of ivabradine compared to placebo on heart rate and hemodynamics in these patients. Participants will be randomly assigned to either receive standard sepsis treatment alone or standard treatment plus ivabradine. Ivabradine is given through the gastrointestinal tract every 12 hours with a goal to maintain heart rates between 70 and 94 beats per minute for up to 96 hours after starting therapy. The study follows patients for 28 days to assess heart rate control, organ function, length of intensive care stay, adverse events, and mortality. During the study, heart rate, blood pressure, cardiac output, and other heart function measures are monitored closely, especially within the first 96 hours. Researchers also track organ failure scores, need for organ support, and survival over 28 days. Participants receive regular assessments to measure treatment effects and safety. The study is planned to enroll 172 adult patients in intensive care units and lasts until May 2027.
CONDITIONS
Brief Title
Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or above
- Being treated in an intensive care unit
- Diagnosed with sepsis according to Sepsis-3.0 criteria requiring antimicrobial agents and an acute increase in SOFA score of at least 2 points
- Mean arterial pressure maintained at 65 mmHg or higher with adequate volume resuscitation and vasopressor therapy
- Stable hemodynamics 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...
- Prior 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
- Known seizure disorder
- Any contraindication to gastrointestinal drug administration
- Pregnant or lactating women
- Use of potent CYP3A4 inhibitors such as certain antifungals, macrolide antibiotics, or HIV protease inhibitors
- Active bleeding
- Cardiac dysfunction from non-septic causes including recent acute myocardial infarction, chronic severe cardiac dysfunction, congenital heart disease, pericardial tamponade, severe aortic regurgitation, or aortic coarctation
- Sinoatrial or atrioventricular conduction blocks, sick sinus syndrome, or pacemaker dependency
- Refractory shock despite treatment with high-dose vasopressors and other therapies
- Use of beta blockers within 24 hours before enrollment
- Pheochromocytoma
- Post cardiopulmonary resuscitation
- Participation in another interventional clinical study
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 96 hours
Participants receive standard treatment for sepsis. Those in the ivabradine group receive enteral ivabradine every 12 hours for up to 96 hours to control heart rate between 70 and 94 bpm, with dose adjustments as needed based on heart rate.
Heart rate is assessed before each ivabradine dose every 12 hours
Follow-up
Duration - Up to 28 days
Participants are followed for up to 28 days after treatment to monitor outcomes such as mortality, organ support needs, ICU stay length, and adverse events.
Follow-up assessments during the 28-day period
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
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Research Team
Z
Zhenhui Zhang, PhD
W
Weiyan Chen, PhD
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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