Study of Ivabradine for Heart Rate Control in Adults with Sepsis to Improve Blood Flow and Outcomes

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.

Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis