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To Study Effect of the Combination of Midodrine and Tolvaptan (drug) Versus Tolvaptan Alone in Patients With Severe Hyponatremia in Cirrhosis (Liver Disease).

To Study Effect of the Combination of Midodrine and Tolvaptan Versus Tolvaptan Alone in Patients With Severe Hyponatremia in Cirrhosis(TOLMINA Trial) - An Open Label Placebo Randomized Control Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036265
Enrollment
220
Registered
2021-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: Tolvaptan with Midodrine: Drug: Tolvaptan Tablets â?¢ Tolvaptan15 mg once a day for 7 days, stat with 7.5 mg and titrate to 15 mg in 24 hours max30 mg Drug: Midodrine Oral Tablet â?¢ M

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Child B/C cirrhosis 2) Hyponatremia( severe) 3) Written informed consent 4) Age-18-70 years

Exclusion criteria

Exclusion criteria: 1. AKI(1.5mg/dl) 2. Sepsis 3. Underlyig CKD 4. High risk varices 5. Recent Bleed in 2 weeks 6. Acute Symptomatic hyponatremia 7. SIADH 8. Hypothyroidism 9. Severe cardiopulmonary disease 10. Cerebrovascular accident 11. Multiple strokes; Pseudohyponatremia

Design outcomes

Primary

MeasureTime frame
Improvement in Na+ to 125meq/LTimepoint: 1 week—

Secondary

MeasureTime frame
Change in body weightTimepoint: Day 7 and 30;Changes in osmolality , urine volume,urinay sodium excretion in bodyTimepoint: 0,1day,3day,1week ,2 week,1 month;Development of AKITimepoint: 7 days;Failure to achieve sodium concentration to 125 meq/LTimepoint: 7 days;Improvement in ascitesTimepoint: Day 7 and 30;Improvement in sodium (120 -125 meq/L)Timepoint: 3,5 days;Improvement in sodium concentration from base line to 130 meq/lTimepoint: day 7;Maintenance of sodium concentrationTimepoint: Day 14 and 30;Mean Arterial pressureTimepoint: Day 1,7,14, and 30];RBC water and sodium concentration in RBC cellTimepoint: Day 7 and day 30;Reduction in clinical complications(AKI,HE) in patients with hyponatreTimepoint: 1 week, 1 month—

Countries

India

Contacts

Public ContactDr Shiv Kumar Sarin

Institute of Liver and Biliary Sciences

shivsarin@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026