Status:
RECRUITING
COOLEY- Study: ACute on ChrOnic Liver FailurE Using the CYtosorb Device
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
CytoSorbents Europe GmbH
Conditions:
Acute-On-Chronic Liver Failure
Anticoagulant Adverse Reaction
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
The study team wants to investigate the effect of Cytosorb hemoadsorption on the bilirubin level as well as on the ammonia level changes induced by the therapy in patients with Acute on Chronic Liver ...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
June 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06079021
Start Date
June 8 2024
End Date
September 30 2027
Last Update
December 10 2024
Active Locations (1)
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1
UZA
Edegem, Antwerp, Belgium, 2650