Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Guangzhou Medical University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patients who had received ivabradine therapy or known allergy to it prior to randomization.
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.
Trial design
Treatments tested in this trial
- Ivabradine
Treatment groups
172 Participants
are divided into 2 treatment groupsSponsors and collaborators
Second Affiliated Hospital of Guangzhou Medical University
Lead sponsor
The Third Affiliated Hospital of Guangzhou Medical University
Collaborator
Source ClinicalTrials.gov