TCTR20200604013
Completed
Phase 2
Effects of mineralocorticoid receptor antagonist on intradialytic hypertension: a multicenter, double-blind, randomized crossover study
ampang hospital0 sites49 target enrollmentJune 4, 2020
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Intradialytic hypertension
- Sponsor
- ampang hospital
- Enrollment
- 49
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. ESRD patients (defined by Kidney Disease Initiative Global Outcome (KDIGO)
- •Guideline 2012\) requiring chronic hemodialysis
- •2\. Hemodialysis vintage more than 12 weeks
- •3\. Hemodialysis with at least 2 sessions per week
- •4\. History of intradialytic hypertension (defined by an increase in systolic blood pressure \>15 mmHg or mean arterial pressure \>10 mmHg during hemodialysis) at least 30% of their dialysis sessions during the past 12 weeks
Exclusion Criteria
- •1\. Serum potassium \>5\.5 mEq/L or \<2\.5 mEq/L
- •2\. Active cardiac, pulmonary or hepatobiliary tract disease
- •3\. Active infection or sepsis
- •4\. Active malignancy
- •5\. Cirrhosis
- •6\. Prior treatment with spironolactone in past 4 weeks
- •7\. Contraindication to spironolactone
- •8\. Interdialytic weight gain more than 6%
Outcomes
Primary Outcomes
Not specified
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