Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using CytoSorb device for patients with acute on chronic liver failure

Official title: COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device

Run by University Hospital, Antwerp · NCT06079021 · Data updated 2026-11-12

This study tests if using the CytoSorb device can help lower bilirubin and ammonia levels and improve muscle strength in patients with severe liver failure.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorUniversity Hospital, Antwerp
Academic / other
Locations1 site (Edegem, Antwerp)
StatusRecruiting
StartedJune 8, 2024
Main results expectedSeptember 30, 2027
Study endsDecember 31, 2027
Registry record updatedMay 1, 2026
Trial IDNCT06079021 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adult patients aged 18 and older with ACLF grade 2 or 3 admitted to the University Hospital of Antwerp.

Probably not a fit

Patients who have made a prior decision to stop further treatment within the next 24 hours or those who refuse participation will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of the CytoSorb hemoadsorption device on bilirubin and ammonia levels in patients with acute on chronic liver failure (ACLF) grades 2 and 3. It aims to assess the prevalence and development of sarcopenia through ultrasound imaging of muscle mass and handgrip strength measurements. The study will compare these outcomes in patients receiving standard medical care with and without the CytoSorb device. Additionally, it will evaluate the reliability of ultrasound in quantifying muscle mass in chronic liver disease.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with acute on chronic liver failure by effectively managing bilirubin and ammonia levels.

How similar studies have gone: While the use of hemoadsorption devices is established, this specific application in ACLF is novel and has not been extensively tested in previous studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* adult patients (≥ 18 years) admitted to the University Hospital of Antwerp (UZA), Belgium.

  * Written informed consent from patient or if not possible due to encephalopathy (\> grade 2): legal representative
  * acute-on-chronic liver failure (ACLF) grade ≥ 2:

    * Acute decompensation event (identifiable trigger)
    * Hepatic encephalopathy grade ≥ 2
    * Acute kidney injury (AKI) according to Kidney Disease: Improving Global Outcome (KDIGO) criteria stage 3 (≥ 3-fold increase of serum creatinine OR increase of serum creatinine to ≥ 4 mg/dl OR urine output ≤ 0.3 ml/kg/h for ≥ 24 hours OR anuria for ≥ 12 hours)
    * Serum bilirubin ≥ 10 mg/dl
    * Hemodynamic instability with vasopressor support (norepinephrine \> 0.05 mcg/kg/min)

Exclusion Criteria:

* • known patient will against participation in the study or against the measures applied in the study

  * a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours
  * no complete remission of malignancy including hepatocellular carcinoma within the past 12 months
  * ongoing intermittent or CRRT before study inclusion

Where it's running

  • Uza
    Edegem, Antwerp, Belgium
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.