Randomized controlled trial comparing the efficacy of Furosemide vs Torsemide in cirrhotic patients with newly diagnosed ascites

A Prospective randomized controlled Open labelled two arm pilot study with blinded endpoints (PROBE) to evaluate the effect of Torsemide spironolactone vs Furosemide spironolactone combination in cirrhotic patients with newly diagnosed ascites - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067631

Enrollment

100

Registered

2024-05-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Health Condition 1: K74- Fibrosis and cirrhosis of liver

Interventions

Intervention1: Torsemide and Spironolactone: Torsemide 10mg and Spironolactone 50mg once daily dosing in the morning for 28 days Control Intervention1: Furosemide and Spironolactone: Furosemide 20mg a

Eligibility

Inclusion criteria

Inclusion criteria: 1 Cirrhosis diagnosed by imaging and or biopsy with newly diagnosed ascites with Ascitic fluid Protein less than 2.5g per dL, SAAG more than 1.1 2 Cirrhosis as evidenced by USG or Cross-Sectional imaging 3 Serum Creatinine less than 1.5mg per dl 4 Informed consent

Exclusion criteria

Exclusion criteria: 1 Spontaneous bacterial peritonitis 2 Pregnancy 3 Serum Creatinine more than 1.5 mg per dl 4. Urine albumin is to Creatinine ratio more than 500mg per gm creatinine 5 Poorly controlled diabetes, fasting glucose more than 200mg per dl 6.SIADH, as per Bartter Schwartz criteria 7.Anuria, urine volume less than 100ml per day 8.Cerebrovascular accident within 30 days prior to the study medication.

Design outcomes

Primary

Measure	Time frame
Efficacy to control ascites in patients with cirrhosis using the mean change in body weight and need for large volume paracentesisTimepoint: 28 days	—

Secondary

Measure	Time frame
1.To assess the therapeutic drug monitoring of both drugs 2.To study the treatment emergent complications of therapy a.Dyselectrolytemia (Na+, K+, Mg ++, Ca++) b.Change in urinary Na+, K+ c.Acute kidney Injury defined by KDIGO criteria( Kidney disease improving global outcome) and Need for renal replacement therapy d.Muscle cramps using Cramps questionnaire {1} e.Hepatic Encephalopathy by West Haven Criteria f.Need for dose escalation g.Mean arterial pressure h.28-day survival 3.To evaluate the Quality of Life of patients using WHO HQOL bref (World health organization quality of life brief version){2} 4.To assess the incremental cost-effectiveness ratio Timepoint: 28 days	—

Measure

Time frame

1.To assess the therapeutic drug monitoring of both drugs 2.To study the treatment emergent complications of therapy a.Dyselectrolytemia (Na+, K+, Mg ++, Ca++) b.Change in urinary Na+, K+ c.Acute kidney Injury defined by KDIGO criteria( Kidney disease improving global outcome) and Need for renal replacement therapy d.Muscle cramps using Cramps questionnaire {1} e.Hepatic Encephalopathy by West Haven Criteria f.Need for dose escalation g.Mean arterial pressure h.28-day survival 3.To evaluate the Quality of Life of patients using WHO HQOL bref (World health organization quality of life brief version){2} 4.To assess the incremental cost-effectiveness ratio Timepoint: 28 days

—

Countries

India

Contacts

Public ContactDr Arun Valsan

Amrita School of Pharmacy

narmadha@pharmacy.aims.amrita.edu8411051156

Outcome results

None listed

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