Status:
UNKNOWN
Evaluation of Albumin and Midodrine Versus Albumin Alone in Outcome of Refractory Ascites in Patients With Decompensated Cirrhosis.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The project is about evaluation of albumin and midodrine versus albumin alone in outcome of refractory ascites in patients with decompensated cirrhosis. Cirrhosis is a leading cause of disability and...
Detailed Description
Study population All patients with decompensated cirrhosis with refractory ascites who get admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who fulfilthe inclusi...
Eligibility Criteria
Inclusion
- \- Cirrhosis with refractory ascites
Exclusion
- \- Recent Gastrointestinal bleeding within 7 days
- Systemic arterial hypertension (\>160/90mmhg)
- Presence of hepatocellular carcinoma or portal vein thrombosis, Budd-chiari syndrome.
- Pregnancy
- No use of drugs affecting systemic hemodynamics 7 days prior to enrolment
- Patients with Cardiovascular disease (NYHA \> II) or chronic obstructive pulmonary disease
- Refusal to participate
- Known or suspected hypersensitivity to albumin
- Prior TIPS
- Post liver or kidney transplantation
- Patients enrolled in other clinical trials
- Extrahepatic malignancy
- Patients on cardiac glycosides like digoxin, phenylephrine, ephedrine, thyroid hormones, ergot derivatives, salt retaining steroids like fludrocortisone, MAO inhibitors, alpha blockers metformin and ranitidine (known to have interactions with midodrine)
- Patients with intrinsic kidney disease, organ nephropathy and CKD stage 4 and
- MELD \> 30 and extremely moribend patient
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 19 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04816240
Start Date
May 15 2021
End Date
March 19 2022
Last Update
June 15 2021
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070