Albumin for Liver Cirrhosis

Overseen By Lynn F. Buchwalder, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Anahita Rabiee MD MHS

Must be taking: Diuretics

Must not be taking: Other diuretics

Disqualifiers: Low GFR, Variceal bleeding, Heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot change your oral diuretic regimen in the 7 days before starting the study. Some diuretics are not allowed, so you may need to adjust your medications accordingly.

What data supports the effectiveness of the drug albumin for liver cirrhosis?

Research shows that albumin can help manage complications in liver cirrhosis, such as reducing the risk of heart and circulation problems after fluid removal and improving response to other treatments for kidney issues. It also helps prevent fluid buildup and infections, making it a useful tool in managing cirrhosis. ^{1 2 3 4 5}

Is albumin safe for humans?

Albumin has been used safely in patients with liver cirrhosis to manage complications like fluid buildup and kidney issues. While its benefits are sometimes debated, it is generally considered safe for human use in these conditions. ^{1 4 5 6 7}

How does the drug albumin differ from other treatments for liver cirrhosis?

Albumin is unique in treating liver cirrhosis because it not only helps expand blood plasma volume but also has antioxidant and immune-modulating properties, which can prevent further liver damage and complications. It is particularly effective in managing ascites (fluid buildup in the abdomen) and preventing kidney issues in cirrhosis patients, offering benefits beyond traditional treatments. ^{1 4 5 8 9}

What is the purpose of this trial?

A small, pilot proof-of-concept placebo-controlled trial to explore the effects of albumin on diuresis in patients with cirrhosis, ascites and lower extremity edema. We will additionally investigate albumin's effect on preventing neurohumoral activation, and acute kidney injury after diuresis.

Eligibility Criteria

This trial is for individuals with liver cirrhosis and ascites, which means they have a scarred liver and fluid buildup in the abdomen. The study aims to include those who also have swelling in their legs due to excess fluid.

Inclusion Criteria

I have advanced liver disease with swelling in my abdomen and legs despite water pills.

Serum albumin of < 3.5 g/dL

Exclusion Criteria

I am taking certain water pills other than spironolactone or furosemide.

I am currently experiencing bleeding from enlarged veins.

I had an infection in my abdomen within the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either albumin or placebo for one dose, followed by a 14-day washout period, then crossover to the alternate treatment

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in neurohumoral markers and kidney function after treatment

1 week

Treatment Details

Interventions

• Albumin

Trial Overview The trial is testing whether infusing albumin (a protein) into the blood can help remove excess fluid more effectively than just saline solution in patients with liver issues. It's a small initial study comparing two groups: one receiving albumin and the other getting saline.

Participant Groups

Group I: Albumin first Active Control 2 Interventions

Albumin for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive placebo for one dose.

Group II: Placebo first Placebo Group 2 Interventions

Placebo for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive albumin for one dose.

Who Is Running the Clinical Trial?

Anahita Rabiee MD MHS

Lead Sponsor

Trials

1

Recruited

20+

Grifols Shared Services North America Inc

Collaborator

Trials

1

Recruited

20+

Findings from Research

A meta-analysis of 10 randomized controlled trials involving 2040 patients found that albumin therapy does not significantly reduce mortality in patients with decompensated liver cirrhosis, regardless of whether it is administered short-term or long-term.

While albumin does not improve survival rates, it is effective in reducing the recurrence of ascites, but it also increases the risk of pulmonary edema, highlighting the need for careful consideration in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can albumin reduce the mortality of patients with cirrhosis and ascites? A meta-analysis of randomized controlled trials. Xu, T., Liu, W., Huang, R.[2023]

Albumin significantly improves outcomes in patients with decompensated liver cirrhosis by reducing the risk of complications such as post-paracentesis cardiocirculatory dysfunction and mortality from infections, highlighting its critical role in management.

Recent research indicates that modified forms of albumin in cirrhosis patients have prognostic value, suggesting that understanding these modifications could lead to improved treatment strategies for end-stage liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Insights About Albumin and Liver Disease. Carvalho, JR., Verdelho Machado, M.[2021]

Targeted intravenous albumin infusions significantly increased serum sodium levels in hospitalized patients with cirrhosis and hyponatremia, indicating a potential benefit in managing sodium levels.

However, despite the increase in sodium, the treatment did not lead to improved outcomes for patients, suggesting that simply raising sodium levels may not be sufficient to enhance prognosis in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Albumin Therapy Does Not Improve Short-Term Outcome in Hyponatremic Patients Hospitalized With Complications of Cirrhosis: Data From the ATTIRE Trial. China, L., Freemantle, N., Forrest, E., et al.[2021]

Albumin treatment significantly reduces mortality in cirrhotic patients suffering from spontaneous bacterial peritonitis (SBP) and hepatic encephalopathy (HE), based on a systematic review of 50 studies involving 5118 participants.

Long-term administration of albumin (over 3 months) is associated with fewer cirrhosis complications, reduced hospital readmissions, shorter hospital stays, and improved quality of life, although no significant benefits were found for liver transplants or serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis: Efficacy and safety of albumin in the prevention and treatment of complications in patients with cirrhosis. Leache, L., Gutiérrez-Valencia, M., Saiz, LC., et al.[2023]

Albumin is a crucial protein in the blood that helps maintain pressure and is linked to better health outcomes; low levels can indicate serious health issues.

In patients with liver cirrhosis, albumin infusion not only helps prevent fluid buildup after procedures like paracentesis but also reduces the risk of complications, making it an effective treatment for cirrhosis and its related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of albumin in cirrhosis: from a hospitalist's perspective. Walayat, S., Martin, D., Patel, J., et al.[2020]

Human albumin infusion significantly reduces mortality in cirrhotic patients, particularly those with spontaneous bacterial peritonitis (SBP) and hepatic encephalopathy (HE), based on a meta-analysis of 42 randomized controlled trials.

The treatment also decreases the incidence of renal impairment and ascites, but does not significantly affect long-term mortality or the occurrence of infections and gastrointestinal bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of human albumin infusion in cirrhotic patients: a systematic review and meta-analysis of randomized controlled trials. Bai, Z., Wang, L., Wang, R., et al.[2023]

Intravenous (IV) albumin did not significantly reduce the risk of renal impairment or mortality in patients with cirrhosis and non-spontaneous bacterial peritonitis, based on a meta-analysis of 3 randomized controlled trials involving 406 subjects.

However, IV albumin was associated with a higher risk of pulmonary edema and may promote recovery from acute-on-chronic liver failure (ACLF), indicating a potential benefit that requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of IV albumin for non-spontaneous bacterial peritonitis infection among patients with cirrhosis: A systematic review and meta-analysis. Wong, YJ., Qiu, TY., Tam, YC., et al.[2021]

Human albumin is recommended for short-term use in patients with decompensated cirrhosis to prevent complications like circulatory dysfunction and hepatorenal syndrome, highlighting its role in managing severe liver conditions.

Recent studies indicate that long-term albumin treatment may improve survival rates and reduce hospitalizations in cirrhosis patients, suggesting potential disease-modifying effects, although more research is needed to optimize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[News for usage of albumin in patients with liver disease]. Cremonese, C., Uschner, FE., Trebicka, J.[2021]

Albumin is effective in treating ascites in cirrhotic patients, particularly in preventing circulatory dysfunction after procedures like large-volume paracentesis and in managing hepatorenal syndrome, due to its properties as a plasma volume expander and its ability to restore oncotic pressure.

The safety profile of albumin is generally favorable, with side effects being rare, and ongoing trials are exploring the long-term benefits of home administration of albumin for preventing and treating ascites in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of human albumin for the treatment of ascites in patients with liver cirrhosis: item of safety, facts, controversies and perspectives. Facciorusso, A., Nacchiero, MC., Rosania, R., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Can albumin reduce the mortality of patients with cirrhosis and ascites? A meta-analysis of randomized controlled trials. [2023]

2. Mexico pubmed.ncbi.nlm.nih.gov

New Insights About Albumin and Liver Disease. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Targeted Albumin Therapy Does Not Improve Short-Term Outcome in Hyponatremic Patients Hospitalized With Complications of Cirrhosis: Data From the ATTIRE Trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Meta-analysis: Efficacy and safety of albumin in the prevention and treatment of complications in patients with cirrhosis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Role of albumin in cirrhosis: from a hospitalist's perspective. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Use of human albumin infusion in cirrhotic patients: a systematic review and meta-analysis of randomized controlled trials. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of IV albumin for non-spontaneous bacterial peritonitis infection among patients with cirrhosis: A systematic review and meta-analysis. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

[News for usage of albumin in patients with liver disease]. [2021]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The use of human albumin for the treatment of ascites in patients with liver cirrhosis: item of safety, facts, controversies and perspectives. [2022]