Taking peoplePhase 4
ALBUMINUS: Dose reduction of human albumin during large-volume paracentesis in patients with cirrhosis
Key facts
- Who runs it
- Amsterdam UMC Stichting
- Where
- Netherlands23 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 634 people, planned
- Started
- 2 Nov 2026
- Expected to end
- 1 Nov 2031
- Type of study
- Interventional
- Record updated
- 26 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Age ≥ 18 years
- Portal hypertension-driven ascites due to cirrhosis requiring LVP
- Documented informed consent to participate
Who cannot take part
- Variceal bleeding within one week prior to presentation
- Patients who have already been included in the study previously
- Systemic infection, defined as documentation or strong clinical suspicion of an infectious source
- Acute-on-chronic liver failure (ACLF) defined as a chronic liver failure consortium organ failure score of 8 or higher (representing ≥ 2 (out of 6) failing organ systems), using the CLIF-C organ failure score
- New-onset AKI before screening and randomization, defined as an increase in serum creatinine of ≥ 26.5 μmol/L within 48 hours, or an increase of serum creatinine to ≥ 1.5 times the baseline creatinine level within 7 days
- Hemodynamic instability, defined as a mean arterial pressure < 60 mmHg
- TIPS procedure in past medical history or planned
- Patients with advanced hepatocellular carcinoma (HCC) stage BCLC-B or higher
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The primary objective of this study is to demonstrate that low-dose IV HA (4 g/L) is non-inferior to the standard 8 g/L regimen in preventing future liver-related decompensation events, defined as spontaneous bacterial peritonitis, hepatorenal syndrome - acute kidney injury (HRS-AKI), variceal bleeding, and hepatic encephalopathy, in patients with cirrhosis undergoing LVP.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Record updated
- 26 October 2026