High Dose Albumin for Ascites

This trial explores the benefits of high-dose albumin treatment for individuals with advanced liver disease and severe fluid retention in the abdomen, known as ascites. Managing ascites typically involves reducing salt intake and using water pills, but these methods are not effective for everyone and can cause other health issues. The trial aims to determine if regular albumin infusions (a type of protein therapy) can prevent these complications and improve survival rates. Participants should have liver cirrhosis and experience stubborn ascites that does not improve with typical treatments and requires frequent fluid removal. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

The trial information does not specify if you need to stop taking your current medications. However, since the trial focuses on patients with refractory ascites who are already on maximum tolerable doses of diuretics, it seems likely that you may continue your current treatment.

Research has shown that using albumin to treat cirrhosis and ascites (fluid buildup in the belly) is safe. One study found that long-term use of albumin helped people live longer and reduced complications related to cirrhosis. It also decreased the need for procedures to remove fluid from the belly.

Unlike the standard treatment for ascites, which involves moderate sodium restriction and diuretics, the investigational treatment uses high-dose intravenous human albumin. Albumin is a protein that helps maintain fluid balance in the body, and by administering it at higher doses, researchers hope to improve symptoms more effectively. This approach could potentially offer faster and more significant relief for patients experiencing fluid buildup, which is why researchers are eager to explore its benefits.

Research has shown that administering albumin over an extended period can benefit individuals with cirrhosis and fluid buildup in the abdomen, known as ascites. In this trial, participants in the intervention arm will receive high-dose intravenous human albumin alongside standard care. One study found that patients who received albumin lived longer over 18 months and required fewer procedures to remove abdominal fluid. Another study discovered that albumin reduced fluid buildup in more than half of the patients by the end of the treatment. These studies suggest that albumin not only helps manage fluid but may also reduce the risk of infections and kidney issues. This treatment is used in many countries, although it is not yet common in the U.S.¹²⁶⁷⁸