Role of Midodrine for prevent of Intradialytic Hypotension: A Randomized- Controlled Trial
Phase 3
Completed
- Conditions
- At least thrice-weekly hemodialysis patients with frequently IDH, which defines as absolute intradialytic nadir systolic BP less than 90 mmHg or a decrease in systolic more than 20 mmHg with accompanying symptoms at least 1 time per week in prior three monthsintradialytic hypotension, IDH, midodrine, hemodialysis, normal calcium dialysate
- Registration Number
- TCTR20211007003
- Lead Sponsor
- Faculty of Medicine, Thammasat University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
1. Age at least 18 years old, 2. End-stage renal disease patients who receive at least thrice weekly hemodialysis, 3. Dialysis vintage at least 3 months, 4. Time of dialysis at least 3 hours per session, 5. Frequently has IDH (which defines as absolute intradialytic nadir systolic BP less than 90 mmHg or a decrease in systolic more than 20 mmHg with accompanying symptoms) at least 1 time per week in prior three months
Exclusion Criteria
1. Post parathyroidectomy within 3 months, 2. Recent myocardial infarction within 3 months, 3. Recent stroke within 3 months, 4. Symptomatic hypocalcemia, 5. Allergic reaction to midodrine, 6. Active thyrotoxicosis, 7. Pheochromocytoma, 8. Narrow-angle glaucoma, 9.
Life expectancy less than 1 year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of intradialytic hypotension 17 weeks Event (Proportion)
- Secondary Outcome Measures
Name Time Method Composite outcome of non-fatal myocardial infarction, non-fatal stroke, and death 17 weeks Event (Proportion),Hospitalization 17 weeks Event (Proportion),Midodrine associated adverse events (hypertension, palpitation, flushing, dyspepsia, restlessness and chest pain) 17 weeks Event (Proportion),The decrease of SBP more than 20 mmHg 17 weeks Event (Proportion),The decrease os MAP more than 10 mmHg 17 weeks Event (Proportion),Nadir SBP 17 weeks mmHg ,Nadir MAP 17 weeks mmHg,Symptoms of IDH (dizziness, headache, cramp, nausea/vominting) 17 weeks Event (Proportion)