Ivabradine on renal functio
Phase 2
Recruiting
- Conditions
- sepesis and renal imparimentKidney Disease
- Registration Number
- PACTR201911806644230
- Lead Sponsor
- amr sobhy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
age 18-60 years old arriving (ASUICU)
diagnosed with sever sepsis = 24 h according to Surviving Sepsis Campaign Guidelines Committee (3) with Sinus rhythm with heart rate = 95 bpm( after adequate resuscitation) and
early renal impairment de?ned by the RIFLE classi?cation (9) (when increased plasma creatinine ×1.5 or GFR decrease >25% of normal range for age or urine output <0.5 ml/kg/h×6 h).
Exclusion Criteria
patients with pre-existing renal or started renal dialysis,
hypersensitivity to the drug, pregnancy, severe hepatic or cardiac insufficiency
, Sick sinus syndrome, Sinu-atrial block pacemaker-dependency ,3rd degree AV block,
Use antifungals of the azole -type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method is to determine whether ivabardine could reduce heart rates to be less than the predefined threshold of 95/min with improvement of kidney function by 25% within 72 hours from the start of treatment.
- Secondary Outcome Measures
Name Time Method is to assess prevention of dialysis, vasopressor dosage consumption, ICU hospital stay and mortality.