drugset / Trial / NCT03367026
Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ivabradine | Small molecule | 2.5 mg | Oral |
| Comparator | Ivabradine | Small molecule | 5 mg | Oral |