Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Midodrine 5mg and Albumin 25%: Midodrine 5mg and Albumin 25%
Control Intervention1: Midodrine 5mg and Albumin Infusion and Standard Medical Therapy (SMT) for six months: ARM A: Weekly
Sponsors
Mylan Pharmaceuticals Pvt Ltd
Takeda Pharmaceticals
Eligibility
Inclusion criteria
Inclusion criteria: All cirrhotic (sinusoidal portal hypertension) patients, age above 18 years, either gender, irrespective of aetiology, with refractoryascites, without acute kidney injury at the time of enrolment.
Exclusion criteria
Exclusion criteria: Patients with (i) cardiac conditions such as ischemic heart disease, congestive cardiac failure, (ii) hepatic encephalopathy (iii) active sepsis such as spontaneous bacterial peritonitis or blood culture positivity, (iv) tuberculous ascites (v) chronic kidney disease, (vi) active malignancy (vii) any contraindications to oral midodrine administration as listed above (viii) any contraindications to intravenous albumin administration as listed above (ix) not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of large volume paracentesis (LVP)Timepoint: Six Months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Overall survival at three and six months 2.Improvement in systemic and renal hemodynamics 3.Incidence of new onset acute kidney injury 4.Reduction in liver disease severity scores 5.Development of new onset complications such as sepsis, variceal bleed, hepatic encephalopathy 6.Improvement in quality of life by CLD questionnaire 7.Safety of treatment. Timepoint: six months | — |
Countries
India
Contacts
Public ContactDr Esther Rani
Gleneagles Global Hospitals
Outcome results
None listed