Evaluation of Albumin and Midodrine in Patients (drug) With Decompensated Cirrhosis (Liver Cirrhosis)
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2021/04/032539
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Cirrhosis with refractory ascites
1.Recent Gastrointestinal bleeding within 7 days
2.Systemic arterial hypertension ( >160/90mmhg)
3.Presence of hepatocellular carcinoma or portal vein thrombosis, Budd-chiari syndrome.
4.Pregnancy
5.No use of drugs affecting systemic hemodynamics 7 days prior to enrolment
6.Patients with Cardiovascular disease (NYHA > II) or chronic obstructive pulmonary disease
7.Refusal to participate
8.Known or suspected hypersensitivity to albumin
9.Prior TIPS
10.Post liver or kidney transplantation
11.Patients enrolled in other clinical trials
12.Extrahepatic malignancy
13.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)
14.Patients with intrinsic kidney disease, organ nephropathy and CKD stage 4 and
15.MELD > 30 and extremely moribend patient
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival free of transplant and TIPSTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Cumulative frequency of large volume paracentesis.Timepoint: 3, 6 and 12 months;Cumulative incidence of liver-related complicationsTimepoint: 3,6 and 12 months;Improvement in frailityTimepoint: 3, 6 and 12 months;Incidence of HRS-AKD, HRS-CKD and HRS AKI in both groups at 1 yearTimepoint: 1 year;Survival free of liver transplant in both groupsTimepoint: 1 year;Survival free of TIPS and transplantTimepoint: 6 months;Survival free of TIPS in both groupsTimepoint: 1 year