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Low‑dose human serum albumin versus standard dose during large‑volume paracentesis in patients with liver cirrhosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves people with liver cirrhosis who need a procedure called large-volume paracentesis to remove excess fluid from the abdomen. During this procedure, participants will receive an intravenous infusion of human serum albumin, a protein that helps keep fluid in the blood vessels. The trial compares the usual dose of albumin (8 g/L) with a lower dose (4 g/L) to determine whether the reduced amount can prevent serious liver‑related problems as effectively as the standard amount. The purpose of the study is to see if a lower dose of the albumin infusion works as well as the standard dose in preventing liver‑related complications.

Participants are randomly assigned to receive either the lower or the standard dose of the albumin infusion at the time of the fluid‑removal procedure and are then followed for up to one year. During this period, they will have regular clinic visits where blood tests and simple questionnaires are used to check for any new health issues, such as infections of the abdominal fluid (spontaneous bacterial peritonitis), kidney problems caused by liver disease (hepatorenal syndrome - acute kidney injury), bleeding from enlarged veins in the esophagus (variceal bleeding), or changes in brain function due to liver failure (hepatic encephalopathy). The study also records overall well‑being and any hospital visits, but no technical details of the measurements are provided.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and randomization
After you agree to join the study, you will be assigned by chance to receive either a low-dose or a standard-dose of albumin during each procedure.
The assignment is kept secret from you and the clinical team until the first treatment.
Step 2
Baseline assessment
You will undergo a series of initial evaluations that include medical history, physical examination, blood tests, and questionnaires about quality of life.
These measurements create a reference point for later comparisons.
Step 3
First large-volume paracentesis with albumin infusion
When a large amount of fluid needs to be removed from the abdomen (called large-volume paracentesis), a needle will be placed by a health professional.
During the same session, an intravenous infusion of albumin solution (albuman 200 g/l) will be given.
If you are in the low-dose group, the infusion will contain 4 g of albumin per litre of fluid removed; if you are in the standard-dose group, the infusion will contain 8 g per litre.
The infusion is administered only during the paracentesis and stops when the fluid removal is completed.
Step 4
Subsequent large-volume paracenteses
Each time another large-volume paracentesis is required during the study period, the same dose of albumin that was assigned to you at the start will be used.
The infusion is given intravenously at the same concentration (4 g/l or 8 g/l) and only for the duration of the fluid removal.
Step 5
Regular follow‑up visits
You will attend scheduled clinic visits approximately every few weeks to a few months over a period of 52 weeks.
During each visit, blood tests will be performed to check kidney function, blood pressure, sodium levels, and other safety parameters.
The medical team will also ask about any new liver‑related problems such as spontaneous bacterial peritonitis, kidney injury (hepatorenal syndrome), variceal bleeding, or hepatic encephalopathy.
Questionnaires about quality of life and health‑care use will be completed at the same visits.
Step 6
Final assessment at week 52
At the end of the 52‑week study period, a comprehensive evaluation will be performed.
The assessment includes the same laboratory tests, clinical examinations, and questionnaires used at baseline.
The results will be used to compare the occurrence of liver‑related decompensation events between the two dose groups.

Who can join the trial?

4 criteria

Be at least 18 years old.
Have fluid buildup in the abdomen called ascites that is caused by increased pressure in the liver’s blood vessels (portal hypertension) and is due to scarring of the liver (cirrhosis).
Require a procedure known as large‑volume paracentesis (LVP) to drain that fluid.
Provide a signed statement of informed consent, showing you understand the study and agree to take part.

Who cannot join the trial?

8 criteria

Having a new kidney problem called acute kidney injury (AKI) right before the study, which means a rapid rise in a blood test called serum creatinine (at least 26.5 µmol/L in two days, or 1.5 times higher than your normal level within a week).
Having unstable blood pressure, defined as a mean arterial pressure lower than 60 mmHg.
Having any active systemic infection, meaning doctors have found or strongly suspect an infection somewhere in your body.
Having had, or planning to have, a TIPS procedure (a special shunt placed in the liver to improve blood flow).
Having advanced liver cancer called hepatocellular carcinoma (HCC) at stage BCLC‑B or higher.
Having bleeding from enlarged veins in the esophagus or stomach (variceal bleeding) within the past week.
Having acute‑on‑chronic liver failure (ACLF), which means your liver disease has suddenly worsened and at least two of six major organ systems are failing, giving a score of 8 or higher on the CLIF‑C organ failure score.
Having already taken part in this study before.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amphia Hospital
Breda, The Netherlands
Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands

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Investigated drugs

Albuman is a sterile solution that contains human serum albumin, a protein normally found in blood. In this study, it is given through an IV line during a procedure called large‑volume paracentesis, which removes excess fluid from the abdomen of people with cirrhosis. The purpose of giving Albuman is to replace the albumin that is lost with the fluid removal and to help keep the body's fluid balance stable. The trial is testing whether using a lower concentration of this albumin solution (4 g per litre) works just as well as the standard higher concentration (8 g per litre) in preventing serious liver‑related complications such as infections, kidney problems, bleeding, and brain changes.

Human Serum Albumin

What is already known about the treatment

Human serum albumin - It is administered as an intravenous solution for infusion, usually at a concentration of 200 g/L. Human serum albumin is a well‑known protein product that is approved and widely described in medical literature. It is mainly used to raise blood volume and keep fluid balance in patients with liver cirrhosis undergoing large‑volume paracentesis, as well as in shock or low‑protein states. The protein works by drawing water into the bloodstream and transporting substances, and it belongs to the plasma‑expander (colloid) class of medications.

Investigated diseases

Liver cirrhosis - Liver cirrhosis is a condition where healthy liver tissue is replaced by scar tissue, which makes it harder for the liver to work properly. The scarring develops slowly over many years, often because of long‑term damage from alcohol use, viral hepatitis, or fatty liver disease. As more scar tissue forms, blood flow through the liver becomes restricted, leading to swelling and fluid buildup in the abdomen. The liver’s ability to filter toxins and produce important proteins gradually declines. Over time, the scarred liver may cause problems such as fluid accumulation, bleeding from enlarged veins, and changes in mental function.