NCT06079021 COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device
| NCT ID | NCT06079021 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Acute-On-Chronic Liver Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-06-08 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-06-08 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Prospective, Single-Center trial, in Patients With Acute on Chronic Liver Failure. Study of Standard Medical Care Plus CytoSorb® Compared to Standard Medical Care Alone in a historical group.
Eligibility 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
Contact & Investigator
Karolien Dams
PRINCIPAL INVESTIGATOR
University Hospital, Antwerp
Frequently Asked Questions
Who can join the NCT06079021 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute-On-Chronic Liver Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06079021 currently recruiting?
Yes, NCT06079021 is actively recruiting participants. Contact the research team at Karolien.Dams@uza.be for enrollment information.
Where is the NCT06079021 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT06079021 clinical trial?
NCT06079021 is sponsored by University Hospital, Antwerp. The principal investigator is Karolien Dams at University Hospital, Antwerp. The trial plans to enroll 20 participants.