Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Midodrine and Albumin and Standard Medical Treatment: Midodrine
Dose: 5mg TDS and could be increase upto 15 mg TDS
Frequency: TDS
Route of Administration: Oral
Duration: 6 months
SMT a
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Cirrhosis with refractory ascites
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival free of transplant and TIPSTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Rakhi Maiwall
Institute of Liver and Biliary Sciences
Outcome results
None listed