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

NCT04679571 | Unknown

• 1 other identifier: ILBS-Cirrhosis-38
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Mortality in both groups

  6 months

Secondary Outcomes (18)

• Incidence of liver-related complications in both groups

  3 months

• Incidence of liver-related complications in both groups

  6 months

• Incidence of liver-related complications in both groups

  12 months

• Survival free of liver transplant in both groups

  6 months

• Survival free of liver transplant in both groups

  12 months

Study Arms (2)

Targeted Albumin with Standard Medical Treatment

EXPERIMENTAL

Patients with serum albumin \<3 g/L with recurrent ascites - Will receive 20 % albumin at 60 grams/week until target serum albumin of 3.0 g/L is achieved following this patients would get 40 grams of albumin every week until ascites resolution or serum albumin \>3.5 g/L. Patients who achieve this target will continue with 20 gm/week until patient has complete resolution of ascites and serum albumin \>3.5 gm/L this patients would receive albumin 20 gms once every 2 weeks

Biological: Albumin; Drug: Standard Medical Treatment

Standard Medical Treatment

ACTIVE COMPARATOR

Standard Medical Treatment- Salt-restriction, diuretics with large volume paracentesis These patients will be put on low sodium diet (2 g/day) and will be given a combination of loop diuretic (furosemide 40-160 mg/day) and a distal acting diuretic (spironolactone 100-400 mg/day) with dose escalation by one step at a time with monitoring for side-effects. Large volume paracentesis (LVP) will be performed along with intravenous albumin (8 g/L ascites removed) as required with record of the frequency of taps. Follow up: 2 week, 4 weeks then every 3 months for 1 year

Drug: Standard Medical Treatment

Interventions

Albumin BIOLOGICAL

Patients with serum albumin \<3 g/L with recurrent ascites - Will receive 20 % albumin at 60 grams/week until target serum albumin of 3.0 g/L is achieved following this patients would get 40 grams of albumin every week until ascites resolution or serum albumin \>3.5 g/L. Patients who achieve this target will continue with 20 gm/week until patient has complete resolution of ascites and serum albumin \>3.5 gm/L this patients would receive albumin 20 gms once every 2 weeks.

Targeted Albumin with Standard Medical Treatment

Standard Medical Treatment DRUG

Standard Medical Treatment- Salt-restriction, diuretics with large volume paracentesis These patients will be put on low sodium diet (2 g/day) and will be given a combination of loop diuretic (furosemide 40-160 mg/day) and a distal acting diuretic (spironolactone 100-400 mg/day) with dose escalation by one step at a time with monitoring for side-effects. Large volume paracentesis (LVP) will be performed along with intravenous albumin (8 g/L ascites removed) as required with record of the frequency of taps. Follow up: 2 week, 4 weeks then every 3 months for 1 year.

Standard Medical Treatment; Targeted Albumin with Standard Medical Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cirrhosis of liver with recurrent ascites.
• Patients with age from 18-70 years

You may not qualify if:

• Renal failure (Creatinine \>1.5mg/dl)
• Recent Gastrointestinal bleeding within 7 days
• Spontaneous bacterial Peritonitis
• Patients with organic nephropathy ( as defined by IAC)
• Patients with Cardiovascular disease or chronic obstructive pulmonary disease
• Systemic arterial hypertension (\>160/90mmhg)
• Presence of hepatocellular carcinoma (outside Milan criteria)( or portal vein thrombosis
• Budd-Chiari Syndrome
• Patients with active sepsis
• Pregnancy
• Patients with hepatic encephalopathy
• No use of drugs affecting systemic hemodynamics 7 days prior to enrolment (except beta-blockers)
• Patients with serum albumin \>3 gm
• Refusal to participate
• Known or suspected hypersensitivity to albumin

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Albumins

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dr Rakhi Maiwall, DM

CONTACT

01146300000; rakhi_2011@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: December 22, 2020
• Study Start: December 30, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 22, 2020

Record last verified: 2020-08

Locations

IN (1)