ALBUMINUS: Dose reduction of human albumin during large-volume paracentesis in patients with cirrhosis
People with severe liver scarring (cirrhosis) often develop a build-up of fluid in their tummy, known as ascites. Doctors regularly drain this fluid using a needle or tube to help relieve pain and breathlessness. After draining large amounts of fluid, patients usually receive a drip containing human albumin, a natural blood protein that helps protect blood pressure and kidneys. Currently, doctors use a standard dose of albumin. The ALBUMINUS trial aims to find out if a lower dose of albumin can protect patients just as well. Researchers want to see if patients receiving a lower dose experience the same low rates of liver and kidney complications. If you take part, you will receive the albumin drip during your regular drainage procedures and have your health tracked for one year. This helps doctors learn the safest and most effective dose for future care.
At a glance
What is this study about?
Cirrhosis is severe scarring of the liver caused by long-term damage. One common and uncomfortable complication is ascites, where large amounts of fluid gather inside the belly. To make patients comfortable and reduce pressure, doctors perform a routine procedure to drain this fluid using a thin tube. Because removing lots of fluid can suddenly drop blood pressure and strain the kidneys, doctors give patients a blood protein called albumin through an intravenous drip.
Albumin acts like a sponge inside the bloodstream, keeping fluid where it belongs and protecting vital organs. At present, medical guidelines suggest giving a set amount of albumin based on how much fluid is removed. However, doctors want to know whether a smaller amount of albumin can give the exact same protection without increasing the risk of complications.
In this study, researchers will compare how well patients do over 52 weeks (one year). They will carefully monitor serious liver complications, such as infections, internal bleeding, kidney problems, and confusion. By finding the most effective dose, doctors hope to provide the best possible care while making the best use of blood-derived medicines.
Key takeaways
- The study tests whether a lower dose of albumin drip is safe and effective when draining belly fluid.
- It is designed for adults with liver cirrhosis who need regular fluid drainage.
- Participants will be followed up by researchers for 52 weeks (one year).
- Doctors will carefully track kidney health, blood pressure, and overall wellbeing.
- Joining is completely voluntary and will not disrupt your regular liver care.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with liver cirrhosis and need large volumes of tummy fluid drained.
Both men and women can join. Because the study focuses on the effects of fluid drainage, you must be someone who needs this routine hospital procedure as part of your ongoing liver care.
Your hospital doctor or research team will review your complete medical history, including your current kidney function and overall health, to confirm whether taking part is safe and suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with liver cirrhosis.
- I have fluid build-up in my tummy (ascites).
- I need hospital procedures to drain large amounts of this fluid.
- I am able to attend follow-up hospital visits over a 12-month period.
What does participation involve?
If you join the study, you will receive albumin through a drip into your vein whenever you have large amounts of tummy fluid drained, just as you normally would. Depending on the study group you are in, you will receive either the standard dose or a reduced dose of albumin.
You will be monitored closely for about 52 weeks (one year). During this time, your care team will check your blood pressure, test your blood and urine to check your kidney function, and ask about your symptoms and quality of life using simple questionnaires. Most of these checks will happen during your regular hospital visits for fluid drainage, so you should not need many extra trips.
Potential risks and benefits
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Common questions
What is human albumin?
Human albumin is a natural protein found in healthy human blood. It is carefully purified from donated blood and used as a medicine to help keep fluid in your blood vessels.
What is large-volume fluid drainage?
It is a standard hospital procedure where a doctor gently inserts a small, temporary tube into your belly to drain away several litres of built-up fluid, making you more comfortable.
Will taking part stop my usual fluid drainage treatments?
No. You will continue to have your tummy fluid drained whenever your doctor decides it is needed.
Can I leave the study if I change my mind?
Yes. You can leave the trial at any time without giving a reason, and your regular medical care will continue as normal.
Does it cost anything to take part?
No. The study treatment and any extra trial-related tests are provided free of charge through the hospital.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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