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Effects of mineralocorticoid receptor antagonist on intradialytic hypertension: a multicenter, double-blind, randomized crossover study

Effects of mineralocorticoid receptor antagonist on intradialytic hypertension: a multicenter, double-blind, randomized crossover study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200604013
Enrollment
49
Registered
2020-06-04
Start date
2021-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intradialytic hypertension Intradialytic hypertension Spironolactone Mineralocorticoid receptor antagonist

Interventions

Patients in intervention arm will be prescribed 2 tablets (50 mg) of spironolactone 30 minutes prior to undergo hemodialysis in every sessions during study period.,Patients in controlled arm will unde
Experimental Drug,No Intervention No treatment
Spironolactone,No intervention

Sponsors

Lampang hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion 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

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%

Design outcomes

Primary

MeasureTime frame
Incidence of intradialytic hypertension 24-week study period Proportion of intradialytic hypertension (%)

Secondary

MeasureTime frame
Intradialytic blood pressure 24-week study period Blood pressure (mmHg),Serum potassium End of study mEq/L,Pre-dialysis blood pressure 24-week study period Blood pressure (mmHg),Post-dialysis blood pressure 24-week study period Blood pressure (mmHg),Prespecified subgroup analyses of the primary outcome 24-week study period diabetes, receiving ACEI/ARB, receiving more than three anti-hypertensive medications and the presence of residual kidney function (RKF),Peak intradialytic blood pressure 24-week study period Blood pressure (mmHg)

Countries

Thailand

Contacts

Public ContactThanawat Vongchaiudomchoke

Department of internal medicine, Lampang hospital

thanawat.lp@cpird.in.th0867964597

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026