Efficacy of Targeted And Response-Guided Albumin Therapy Versus Standard Medical Treatment In Outcomes Of Recurrent Ascites In Patients With Decompensated Cirrhosis.

• Status: Not yet recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Criteria

Inclusion Criteria:

1. Patients with cirrhosis of liver with recurrent ascites.

2. Patients with age from 18-70 years

Exclusion Criteria:

1. Renal failure (Creatinine >1.5mg/dl)

2. Recent Gastrointestinal bleeding within 7 days

3. Spontaneous bacterial Peritonitis

4. Patients with organic nephropathy ( as defined by IAC)

5. Patients with Cardiovascular disease or chronic obstructive pulmonary disease

6. Systemic arterial hypertension (>160/90mmhg)

7. Presence of hepatocellular carcinoma (outside Milan criteria)( or portal vein thrombosis

8. Budd-Chiari Syndrome

9. Patients with active sepsis

10. Pregnancy

11. Patients with hepatic encephalopathy

12. No use of drugs affecting systemic hemodynamics 7 days prior to enrolment (except beta-blockers)

13. Patients with serum albumin >3 gm

14. Refusal to participate

15. Known or suspected hypersensitivity to albumin

16. Prior TIPS

17. Post liver or kidney transplantation

18. Patients enrolled in other clinical trials

19. Extrahepatic malignancy