Incremental hemodialysis Preserve residual kidney function (RKF) Residual kidney function (RKF) Incremental hemodialysis Spironolactone mineralocorticoid receptor antagonist 24-hour urine volume Residual urea clearance (Kru)
Conditions
Interventions
Participants received spironolactone 25 mg once daily in addition to standard care.,Standard care
Spironolcatone group,Control group
Sponsors
Bhumibol Adulyadej Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Incremental (twice weekly) hemodialysis patients 2. Urine output > 500 mL/day 3. Kru >= 2 mL/min/1.73 m2
Exclusion criteria
Exclusion criteria: 1. History of use of angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or mineralocorticoid receptor antagonists (MRAs) prior to study enrollment 2. Serum potassium level > 5.0 mEq/L, or requirement for unscheduled dialysis due to hyperkalemia within 30 days prior to enrollment 3. History of hospitalization within 30 days prior to enrollment 4. Intradialytic hypotension, defined as systolic blood pressure < 90 mmHg during dialysis in more than 30% of dialysis sessions, with associated symptoms or requiring therapeutic intervention within 30 days prior to enrollment 5. Interdialytic systolic blood pressure < 120 mmHg within 30 days prior to enrollment 6. Interdialytic weight gain (IDWG) > 3.5 kg in more than 30% of dialysis sessions within 30 days prior to enrollment 7. Presence of clinical signs or symptoms of fluid overload 8. Other dialysis-related complications that may affect dialysis adequacy, such as vascular access problems or catheter dysfunction 9. Anemia with hemoglobin level < 8 g/dL 10. Known hypersensitivity to spironolactone 11. Pregnancy or breastfeeding 12. Participation in another clinical study prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 24-Hour urine volume week 12 independent-samples t-tests ,Change in residual urea clearance (Kru) week 12 independent-samples t-tests | — |
Secondary
| Measure | Time frame |
|---|---|
| Hyperkalemia and gynecomastia week 4, 8, 12 chi-square test ,Interdialytic weight gain (IDWG) week 12 independent-samples t-tests ,Blood pressure control week 12 independent-samples t-tests ,Change in Beta-2 microglobulin levels week 12 independent-samples t-tests,Change in cardiac biomarker (TropT, NT-proBNP) week 12 independent-samples t-tests,Hospitalization week 12 chi-square test,Time to transition to conventional hemodialysis week 12 independent-samples t-tests,All-cause mortality and cardiovascular mortality week 12 chi-square test | — |
Countries
Thailand
Contacts
Public ContactSitanun Chinangkulpiwat
Renal Unit, Department of Medicine, Bhumibol Adulyadej Hospital, Royal Thai Air Force
Outcome results
None listed