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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of a treatment called albumin for individuals with liver cirrhosis who experience fluid buildup in the belly (ascites) and leg swelling. Researchers aim to determine if albumin helps the body remove excess fluid and prevents kidney problems. The trial includes two groups: one receives albumin first, followed by a placebo (a substance with no active effect), while the other group starts with the placebo and then receives albumin. Suitable candidates have liver cirrhosis with persistent leg swelling despite taking diuretics (medicines that help remove fluid) and a blood protein level of less than 3.5 g/dL. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that albumin is likely to be safe for humans?

Research has shown that albumin has been used in people with liver cirrhosis, yielding promising results. One study found that albumin might help reduce inflammation and improve certain liver conditions. However, debate remains about its overall effectiveness.

Regarding safety, albumin is generally well-tolerated. Some studies have reported that albumin does not cause serious side effects in most cases. However, benefits and safety can vary based on individual circumstances and specific conditions.

For those considering joining a clinical trial, it is reassuring to know that medical settings have previously used albumin, and researchers continue to study its effects to ensure safety and benefit. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cirrhosis?

Unlike the standard treatments for liver cirrhosis, which often involve medications like diuretics, beta-blockers, or even liver transplantation, albumin offers a unique approach. Albumin is a natural protein that helps maintain blood volume and improve circulation, potentially easing the burden on a damaged liver. Researchers are excited because it could provide rapid relief from symptoms and improve quality of life, especially since it can be administered quickly and might reduce the need for more invasive procedures. This makes albumin a promising option for patients seeking alternatives to traditional treatments.

What evidence suggests that albumin might be an effective treatment for liver cirrhosis?

Research has shown that albumin can help treat liver cirrhosis, particularly by managing complications like fluid build-up in the abdomen (ascites) and swelling from fluid retention (edema). Studies have found that high doses of albumin reduce inflammation and improve liver function in people with cirrhosis. In this trial, participants will receive either albumin or a placebo in a crossover design. Albumin is associated with better survival rates in those with severe liver disease. It increases blood volume and protects the kidneys, which is crucial for cirrhosis patients. Overall, albumin shows promise in improving outcomes for people with liver-related issues. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Severe hyponatremia (Sodium <125 mEq/L)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12593439/

Human Albumin infusion in liver Cirrhosis and overt Hepatic ... Notably, recent evidence suggests that high-dosage human albumin is more beneficial for improving inflammation and cirrhosis-related ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2022166

A Randomized Trial of Albumin Infusions in Hospitalized ... Albumin Infusions in Hospitalized Patients with Cirrhosis. 2m 15s. Liver disease causes 2 million deaths per year worldwide and is the leading ...

3. cureus.com cureus.com/articles/410331-efficacy-of-human-albumin-infusion-in-advanced-cirrhosis-and-acute-on-chronic-liver-failure-implications-for-renal-protection-and-oncologic-outcomes.pdf

Efficacy of Human Albumin Infusion in Advanced Cirrhosis ... Decompensated cirrhosis represents the advanced stage of chronic liver disease, characterized by complications such as ascites, variceal ...

4. journals.lww.com journals.lww.com/hep/fulltext/2025/01000/controversies_regarding_albumin_therapy_in.26.aspx

Controversies regarding albumin therapy in cirrhosis Serum albumin levels are reduced in acute and/or chronic liver disease. In cirrhosis, low levels of albumin predict the outcome.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772572322001819

Timely Albumin Improves Survival in Patients With ... Patients with decompensated cirrhosis and end-stage liver disease (ESLD) often require hospital-based care for a number of complications that frequently lead to ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2589555923001167

Use of albumin infusion for cirrhosis-related complications Targeted albumin therapy does not improve short-term outcome in hyponatremic patients hospitalized with complications of cirrhosis: data from the ATTIRE trial.

7. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-023-04587-3

Identification of indications for albumin administration in septic ... Albumin infusion is associated with a reduction in mortality in septic patients with liver cirrhosis under specific circumstances.