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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Patients in the ivabradine treatment arm receive an additional enteral preparation (orally, via nasogastric tube or Jejunum tube) of ivabradine for 4 days. Day 1 : 2.5 mg ivabradine b.i.d. if heart rate ≥90 bpm Day 2,3,4: 2.5 mg ivabradine b.i.d. if 60bpm≥heart rate\<90bpm. 5.0mg ivabradine b.i.d. if heart rate ≥90bpm
mean heart rate
the reduction of the mean heart rate of 24 hours after the start of trial treatment
Time frame: 24 hours
severity of illness
measured by serial APACHE II score monitoring and Sequential Organ Failure Sequential Organ Failure Assessment (SOFA) score monitoringAssessment (SOFA) score monitoring
Time frame: 4 days
mean heart rate
comparison of the mean heart rate between the treatment and control group
Time frame: 4 days
mortality
28-day and 6 months mortality
Time frame: 6 months
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