Effectiveness of Enteral Ivabradine Plus Standard Therapy vs Standard Therapy Alone for Heart Rate Control in Patients with Septic Shock: A Single-blind Randomized Controlled Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background and aims: Persistent tachycardia in septic shock is associated with adverse hemodynamic and clinical outcomes.This study evaluated the efficacy and safety of enteral ivabradine for heart rate control, and its effects on hemodynamic parameters, organ dysfunction and clinical outcomes in patients with septic shock.Patients and methods: This prospective, single-center, single-blind randomized controlled trial (RCT) enrolled 234 adults with septic shock and persistent tachycardia (heart rate >100 beats/min after 24 hours of guideline-directed resuscitation).Participants were randomized to receive either enteral ivabradine plus standard therapy (n = 117) or standard therapy alone (n = 117).Ivabradine was initiated at 5 mg twice daily and titrated to 7.5 mg twice daily for up to 96 hours.The primary outcome was heart rate reduction at 96 hours.Secondary outcomes included changes in mean arterial pressure (MAP), serum lactate, sequential organ failure assessment (SOFA) score, noradrenaline requirement, intensive care unit (ICU) stay duration, and 14-day mortality.Results: At 96 hours, the ivabradine group had significantly lower heart rates than the standard treatment group [median 88 [interquartile range (IQR) 84-94] vs 110 [IQR 99-118] beats/min; p < 0.001].Mean arterial pressure was higher in the intervention group at 96 hours (80 vs 78 mm Hg; p = 0.04).Although between-group differences in serum lactate, SOFA score, and noradrenaline requirement were not statistically significant, the ivabradine group demonstrated significant within-group improvement over time.Ejection fraction was stable, confirming safety.Fourteen-day mortality was 23.9% in the intervention group and 30.8% in controls (absolute risk reduction 6.9%; 95% confidence interval (CI) -4.5 to 18.3; p = 0.38).Intensive care unit stay was comparable.Conclusion: Enteral ivabradine safely lowered heart rate and improved hemodynamics in septic shock patients.No significant mortality benefit was demonstrated, although favorable hemodynamic and metabolic changes were observed during follow-up.Clinical significance: Enteral ivabradine may be a safe adjunct for heart rate control and hemodynamic stabilization in septic shock with persistent tachycardia.Clinical trial registration no: Clinical trial registry of India (CTRI/2024/09/074220).
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7224015137