Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Human albumin, sodium chloride.
- Who it may be relevant to
- Registry conditions: Decompensated Cirrhosis and Ascites. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Denmark, Germany, Hungary, Netherlands +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Multicentre, Double-Blinded and Placebo-Controlled, Trial of Human Albumin in the Treatment of Decompensated Cirrhosis Guided by the MICROB-PREDICT Biomarker
Overview
The goal of this clinical biomarker validation trial is to test the effect of a predictive biomarker panel to human albumin infusions in patients with liver cirrhosis and ascites. The main questions it aims to answer are: * If the predictive biomarker panel can identify patients who are likely to benefit from regular human albumin infusions * If the predictive biomarker panel can lower the number-needed-to-treat of regular human albumin infusions in patients with liver cirrhosis and ascites The predictive biomarker panel will stratify patients into either a high- or low-expected effect of human albumin infusions. Hereafter are participants randomized into treatment arms. Participants in the active treatment arm will receive regular human albumin infusions during a course of 6 months. Infusions will occur every 10th day for the duration of the study. Researchers will compare 20% human albumin infusions with regular 0.9% sodium chloride to identify the effects on the number of liver-related events.
Interventions
- Drug Human albumin
20% Human Albumin infusions (every 10th day +/- 4 days) with dosing according to the participants bodyweight (1.5 grams of albumin per kg bodyweight with a maximum of 100 grams) - Drug sodium chloride
0.9% NaCl infusions (every 10th day +/- 4 days) with dosing according to the corresponding volume used of 20% Human Albumin (1.5 grams of albumin per kg bodyweight with a maximum of 100 grams)
Primary outcome measures
- Cumulative number of liver-related clinical outcomes [Time frame: 6 months]
Secondary outcome measures (12)
- 6-months survival [Time frame: 6 months]
- The number of episodes of acute-on-chronic liver failures [Time frame: 6 months]
- Number of organ failures [Time frame: 6 months]
- Time-to-first liver-related clinical outcome [Time frame: 6 months]
- Change in SF-36 [Time frame: 6 months]
- Change in CLDQ [Time frame: 6 months]
- Change in EQ-5D-5L [Time frame: 6 months]
- Time to first hospital admission (in days) [Time frame: 180 days]
- Number of hospital admissions [Time frame: 180 days]
- Days spent on hospitalization (in days) [Time frame: 180 days]
- Number of intensive care unit admissions [Time frame: 180 days]
- Length of intensive care unit admissions (in days) [Time frame: 180 days]
Eligibility criteria
Inclusion criteria
- Decompensated liver cirrhosis defined as Child-Pugh score 7-12
- Clinical and/or ultrasound evidenced ascites
- Age ≥ 18 years
- At least five days since resolution of a decompensation event or any condition requiring hospitalisation
Exclusion criteria
- Patients with acute or subacute liver failure without underlying cirrhosis
- Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy
- Refractory ascites as defined by the International Ascites Club
- Existing TIPS inserted <6 months ago
- Portal vein thrombosis without signs of cavernous transformation or recanalization
- Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score > 11)
- Hepatic encephalopathy grade III-IV
- Current, planned or previous treatment with direct antiviral agents for hepatitis C virus (HCV) in the last six months Contraindications for human albumin infusion (pulmonary oedema, hypersensitivity etc.)
- Evidence of current malignancy except for non-melanocytic skin cancer and hepatocellular carcinoma within Barcelona Clinic Liver Cancer (BCLC)-0 or BCLC-A
- Presence or history of severe extra-hepatic diseases (e.g.,chronic renal failure requiring hemodialysis, severe heart disease (NYHA > II); severe chronic pulmonary disease (GOLD Score ≥ C), severe neurological and psychiatric disorders, pulmonary arterial hypertension)
- HIV positive or other condition associated with and/or requiring immunosuppression
- Previous liver or other transplantation
- Pregnancy
- Breastfeeding
- Patients who decline to participate, patients who cannot provide prior written informed consent due to other causes than hepatic encephalopathy or patients with hepatic encephalopathy who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker or sufficient ability to provide delayed informed consent
- Physician's denial (investigator considers that the patient will not adhere to the study protocol scheduled, e.g. in case of heavy drinking)
- Participation in another study within 3 months prior to screening
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Germany · 3 centers
- Charité - Universitätsmedizin Berlin — Berlin
- Universitätsklinikum Jena — Jena
- Universitätsklinikum Münster — Münster
Denmark · 2 centers
- Herlev Hospital — Herlev
- Odense University Hospital — Odense
Netherlands · 2 centers
- Academisch Ziekenhuis Leiden — Leiden
- Alrijne Ziekenhuis Leiden — Leiderdorp
Spain · 2 centers
- Hospital Clinic Barcelona — Barcelona
- Hospital Del Mar — Barcelona
Belgium · 1 center
- Katholieke Universiteit Leuven — Leuven
Hungary · 1 center
- Debreceni Egyetem — Debrecen
United Kingdom · 1 center
- King's College Hospital — London
Publications
- Torp N, Israelsen M, Coenraad M, Papp M, Shawcross D, Korenjak M, Angeli P, Laleman W, Juanola A, Gines P, Trebicka J, Krag A; MICROB-PREDICT Consortium. Personalised human albumin in patients with cirrhosis and ascites: design and rationale for the ALB-TRIAL - a randomised clinical biomarker validation trial. BMJ Open. 2024 Feb 14;14(2):e079309. doi: 10.1136/bmjopen-2023-079309. PMID 38355195
Identifiers
NCT: NCT05056220 · 2022-501006-34-01 · 825694