Randomized controlled trial comparing the efficacy of Furosemide vs Torsemide in cirrhotic patients with newly diagnosed ascites
Phase 4
- Conditions
- Health Condition 1: K74- Fibrosis and cirrhosis of liver
- Registration Number
- CTRI/2024/05/067631
- Lead Sponsor
- Amrita school of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy to control ascites in patients with cirrhosis using the mean change in body weight and need for large volume paracentesisTimepoint: 28 days
- Secondary Outcome Measures
Name Time Method 1.To assess the therapeutic drug monitoring of both drugs <br/ ><br>2.To study the treatment emergent complications of therapy <br/ ><br>a.Dyselectrolytemia (Na+, K+, Mg ++, Ca++) <br/ ><br>b.Change in urinary Na+, K+ <br/ ><br>c.Acute kidney Injury defined by KDIGO criteria( Kidney disease improving global outcome) and Need for renal replacement therapy <br/ ><br>d.Muscle cramps using Cramps questionnaire {1} <br/ ><br>e.Hepatic Encephalopathy by West Haven Criteria <br/ ><br>f.Need for dose escalation <br/ ><br>g.Mean arterial pressure <br/ ><br>h.28-day survival <br/ ><br>3.To evaluate the Quality of Life of patients using WHO HQOL bref (World health organization quality of life brief version){2} <br/ ><br>4.To assess the incremental cost-effectiveness ratio <br/ ><br>Timepoint: 28 days