comparison of efficacy between tolvaptan and midodrine
Not Applicable
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2024/04/065928
- Lead Sponsor
- Amrita School of pharmacy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method improvement in ascites (by measuring body weight, abdominal girth, ultrasound)Timepoint: 28 days
- Secondary Outcome Measures
Name Time Method 1.serum drug concentration of tolvaptan (TDM) <br/ ><br>2.mean change in serum sodium levels <br/ ><br>3.to determine prevalence of drug induced adverse drug reactions <br/ ><br>4. to assess the incremental cost effectiveness ratioTimepoint: 28 days
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie tolvaptan and midodrine's effects on hyponatremia in cirrhotic patients?
How does the combination of midodrine and tolvaptan compare to midodrine alone in treating refractory ascites with hyponatremia?
Which biomarkers are associated with response prediction to midodrine or tolvaptan in cirrhosis with hyponatremia?
What are the potential adverse events and management strategies for tolvaptan and midodrine in cirrhotic patients?
Are there alternative diuretic combinations or novel therapies for hyponatremia-related refractory ascites in liver cirrhosis?