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ALBUMINUS: Dose reduction of human albumin during large-volume paracentesis in patients with cirrhosis
EU CTIS ID: 2026-526167-38-00
What this study is testing
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.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Age ≥ 18 years.
- • Portal hypertension-driven ascites due to cirrhosis requiring LVP.
- • Documented informed consent to participate.
You likely can't join if
- • 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.
- • Systemic infection, defined as documentation or strong clinical suspicion of an infectious source.
- • TIPS procedure in past medical history or planned.
- • Patients with advanced hepatocellular carcinoma (HCC) stage BCLC-B or higher.
- • Variceal bleeding within one week prior to presentation.
See the full eligibility criteria
- • Age ≥ 18 years.
- • Portal hypertension-driven ascites due to cirrhosis requiring LVP.
- • Documented informed consent to participate.
- • 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.
- • Systemic infection, defined as documentation or strong clinical suspicion of an infectious source.
- • TIPS procedure in past medical history or planned.
- • Patients with advanced hepatocellular carcinoma (HCC) stage BCLC-B or higher.
- • Variceal bleeding within one week prior to presentation.
- • 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.
- • Patients who have already been included in the study previously.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.