Using CytoSorb device for patients with acute on chronic liver failure
COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT06079021 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older with ACLF grade 2 or 3 admitted to the University Hospital of Antwerp.
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.
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 performed: While the use of hemoadsorption devices is established, this specific application in ACLF is novel and has not been extensively tested in previous studies.
Eligibility criteria
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 this trial is running
Edegem, Antwerp
- Uza — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Karolien Dams — University Hospital, Antwerp
- Study coordinator: Karolien Dams
- Email: Karolien.Dams@uza.be
- Phone: +3238215175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.