Role of Midodrine for prevent of Intradialytic Hypotension: A Randomized- Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20211007003

Enrollment

Registered

2021-10-07

Start date

2021-11-01

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

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 months intradialytic hypotension, IDH, midodrine, hemodialysis, normal calcium dialysate

Interventions

10-mg midodrine oral 30 minutes prior to each consecutive dialysis session for 2 months (24 sessions),Placebo oral 30 minutes prior to each consecutive dialysis session for 2 months (24 sessions)

Experimental Drug,Experimental Drug

Midodrine,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Incidence of intradialytic hypotension 17 weeks Event (Proportion)	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Thailand

Contacts

Public ContactSithichai Kunawathanakul

Thammasat University Hospital

s_k@kkumail.com6629269999

Outcome results

None listed

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