Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis (NCT05882708) | Clinical Trial Compass
RecruitingPhase 4
Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis
China172 participantsStarted 2023-06-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult patients aged 18 years or above.
✓. Being treated in an intensive care unit.
✓. Sepsis is diagnosed according to Sepsis-3.0 criteria, which is defined as patients requiring antimicrobial agents due to confirmed or suspected infection, acute increase in the SOFA score at least 2 points.
✓. Mean arterial pressure (MAP) is maintained ≥65 mmHg with adequate volume resuscitation and vasopressor therapy. Volume resuscitation is considered adequate when Central Venous Pressure (CVP) \> 8mmHg, global end-diastolic volume index (GEDI) \> 680ml/m2 and resting inferior vena cava (IVC) diameter \> 1.5cm.
✓. Patients are in a relatively stable period of hemodynamics, as defined that the targe mean arterial pressure are maintained with the same dosage of vasopressors for at least 2 h.
✓. Sinus rhythm with heart rate ≥ 95bpm maintain for at least 2 hours but less than 72 hours.
Exclusion criteria
✕. Patients who had received ivabradine therapy or known allergy to it prior to randomization.
✕
What they're measuring
1
The difference of a reduction in heart rate
Timeframe: 96 hours
2
The difference in MAP
Timeframe: 96 hours
3
The difference in CI
Timeframe: 96 hours
4
The difference in LVEF
Timeframe: 96 hours
5
The difference in SVI
Timeframe: 96 hours
6
The difference in VIS
Timeframe: 96 hours
Trial details
NCT IDNCT05882708
SponsorSecond Affiliated Hospital of Guangzhou Medical University
. Patients with severe liver dysfunction (Child-C grade).
✕. Patients with a history of pre-existing chronic renal failure (glomerular filtration rate less than 15 ml/min/1.73 m2), except patients treated with continuous renal replacement therapy (CRRT).
✕. Patients with known seizure disorder.
✕. Patients with any contraindication to gastrointestinal drug administration.
✕. Pregnant or lactating patients.
✕. patients requiring the use of potent cytochrome CYP3A4 inhibitors such as antifungals of the azole-type (specifically ketoconazole and itraconazole), macrolide antibiotics (specifically clarithromycin and erythromycin) and HIV protease inhibitors (specifically nelfinavir and ritonavir).