View clinical trials related to Decompensated Cirrhosis.
Filter by:Decompensated cirrhosis has a high overall mortality rate. There is a large unmet need for safe and alternative therapeutic potions. This clinical trial is to inspect the efficiency and safety of mesenchymal stem cells (MSCs) therapy for decompensated cirrhosis.
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. Clinical data from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. In this retrospective study, the incidence of re-compensation and its clinical characteristics were mainly explored.
The current prospective randomized controlled trial would aim to study the efficacy of targeted albumin therapy versus standard medical treatment in reduction in 6-month mortality in recurrent ascites in patients with decompensated cirrhosis. Additionally, we aim to evaluate the efficacy of albumin in decreasing the incidence of complications: paracentesis induced circulatory dysfunction (PICD), AKI, hyponatremia, bacterial infections, hepatic encephalopathy and variceal bleed, impact on systemic hemodynamics and portal pressures, renal reserve as assessed by biomarkers and on immunomodulation. In this open labeled randomized study, consecutive cirrhotic patients, fulfilling the inclusion criteria and exclusion criteria will be enrolled in the study. The patients will be randomized to 2 groups by the clinical trial coordinator (CTC). The CTC will be blind to the patient and treatment received, and the allocation concealment by the sequentially numbered opaque sealed envelopes (SNOSE) technique would be done. Patients would be assessed every 2 weeks for first 8 weeks with serum albumin levels, ascites grade and use of diuretics and then every 3 months. The treatment would receive targeted albumin therapy as detailed in methods while patients in the other group would receive standard medical treatment. The primary outcome of the study would be evaluation of 6-month mortality while secondary outcome measures would be the incidence of liver-related complications at 3, 6 and 12 months, survival free of liver transplant and TIPS in both groups at 6 months and 1 year, improvement in quality of Life as assessed by short form survey-36 version (SF-36) at 6 and 12 months, improvement in renal reserve (as assessed by renal biomarkers) at 3, 6 and 12 months, reduction in the frequency of large volume paracentesis at 3, 6 and 12 months and change in immune parameters at 3 and 6 months.