COMPARISON OF MIDODRINE+STANDARD MEDICAL THERAPY AND STANDARD MEDICAL THERAPY ALONE IN CIRRHOSIS ASSOCIATED REFRACTORY ASCITES PATIENTS
Phase 4
- Conditions
- Health Condition 1: K74- Fibrosis and cirrhosis of liver
- Registration Number
- CTRI/2024/04/065206
- 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
Definite history of cirrhosis with refractory ascites, ascites evidenced by USG and stable renal function.
Exclusion Criteria
Heart failure with ascites, serum creatinine greater than 1.5 mg/dl, anuria, gastrointestinal bleeding, HRS, grade 2 encephalopathy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Control of ascites determined by change in weight, need of LVP, USG imaging.Timepoint: 28 days
- Secondary Outcome Measures
Name Time Method Determine serum drug concentration of midodrine, responsiveness to midodrine by assessing mean arterial pressure, urine sodium and pottassium, renal function and liver function, assess change in serum sodium and pottasium and to assess treatment emergent ADRs.Timepoint: 28 days