Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine (REHSI)
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|ClinicalTrials.gov Identifier: NCT03367026|
Recruitment Status : Unknown
Verified October 2017 by Peking Union Medical College Hospital.
Recruitment status was: Not yet recruiting
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sepsis, Severe||Drug: Ivabradine Oral Product||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Reducing Elevated Heart Rate in Patients With Severe Sepsis by by the "Funny Channel" Current (If) Inhibitor Ivabradine|
|Estimated Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Active Comparator: Ivabradine oral product
Patients in the ivabradine treatment arm receive interventions:an additional enteral preparation (orally, via nasogastric tube or Jejunum tube) of ivabradine for 4 days.
Drug: Ivabradine Oral Product
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
2.5 mg ivabradine b.i.d. if 60bpm≥heart rate<90bpm. 5.0mg ivabradine b.i.d. if heart rate ≥90bpm
Other Name: routine therapy
No Intervention: control group
All patients receive established medical therapy according to current guidelines and therapeutic standards.
- mean heart rate [ Time Frame: 24 hours ]the reduction of the mean heart rate of 24 hours after the start of trial treatment
- severity of illness [ Time Frame: 4 days ]measured by serial APACHE II score monitoring and Sequential Organ Failure Sequential Organ Failure Assessment (SOFA) score monitoringAssessment (SOFA) score monitoring
- mean heart rate [ Time Frame: 4 days ]comparison of the mean heart rate between the treatment and control group
- mortality [ Time Frame: 6 months ]28-day and 6 months mortality