Status:
UNKNOWN
Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Sepsis, Severe
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 poin...
Eligibility Criteria
Inclusion
- Severe sepsis due to coronary and non-coronary etiology
- Severe sepsis diagnosed ≤ 24 h
- Sinus rhythm with heart rate ≥ 100bpm
- Written informed consent or identified or suspected positive will with respect to the trial treatment
Exclusion
- Patients who have not yet completed the 18th year of age
- Pregnancy, lactation
- Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate \<30ml/min
- severe hepatic insufficiency
- Sick sinus syndrome
- Sinu-atrial block
- pacemaker-dependency 8.3rd degree AV block
- Use of potent cytochrome P450 3A4 inhibitors such as antifungals of the azole -type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see Summary of Product Characteristics (SPC))
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03367026
Start Date
January 1 2018
End Date
June 30 2021
Last Update
December 8 2017
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