FindTrial
Sign In

comparison of efficacy between tolvaptan and midodrine

Prospective Randomized Controlled Trial to Assess the Comparative Efficacy of Midodrine and Tolvaptan Combination Versus Midodrine Therapy in Refractory Ascites in Cirrhotic Patients with Hyponatremia with blinded endpoint assessment.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065928
Enrollment
35
Registered
2024-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: tolvaptan + midodrine: tolvaptan 15mg od + midodrine 5mg tid (1 week) tolvaptan 15mg bd + midodrine 10mg tid (3 weeks) Control Intervention1: Midodrine: Midodrine 5mg TID (1 week) M

Sponsors

Amrita School of pharmacy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed refractory ascites patients as per the AASLD and EASL guidelines. Definite history of cirrhosis with hyponatremia. Consenting to follow-up. CHILD PUGH - B/C cirrhosis.

Exclusion criteria

Exclusion criteria: Pregnancy. AKI (S. creatinine 1.5mg/dL) and kidney problems. Sepsis. High risk varices. Cerebrovascular accidents within 30 days before the study medication. Acute symptomatic hyponatremia and pseudohyponatremia SIADH. Hypothyroidism. Cerebrovascular accidents. Multiple strokes.

Design outcomes

Primary

MeasureTime frame
improvement in ascites (by measuring body weight, abdominal girth, ultrasound)Timepoint: 28 days—

Secondary

MeasureTime frame
1.serum drug concentration of tolvaptan (TDM) 2.mean change in serum sodium levels 3.to determine prevalence of drug induced adverse drug reactions 4. to assess the incremental cost effectiveness ratioTimepoint: 28 days—

Countries

India

Contacts

Public ContactDr Arun Valsan

Amrita Institute of Medical Sciences

drarunvalsan@gmail.com918411051156

Outcome results

None listed

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