drugset / Trial / NCT03367026

Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine

NCT03367026

RandomizedParallel-groupTriple-blindTreatment

Summary

REHSI is a prospective, multi-center, open label, randomized, controlled two arms, to evaluate the ability of ivabradine to reduce an elevated heart rate in septic shock patients. The primary end point is the reduction of heart rate within 24 hours. This trial will randomize 70 patients (men and women, aged ≥ 18 years) with newly diagnosed Septic Shock (despite adequate fluid resuscitation, were still requiring high-dose norepinephrine (NE) to maintain a mean arterial pressure (MAP) ≥65 mmHg , and had a tachycardia \>100 beats per minute (bpm). Treatment period will last 4 days. All patients will be followed for up to six months.

Timeline

Start
2018-01-01
Primary completion
2020-12-31
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ivabradine Small molecule 2.5 mg Oral
Comparator Ivabradine Small molecule 5 mg Oral