RecruitingNot ApplicableNCT06079021
COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device
Sponsor
University Hospital, Antwerp
Enrollment
20 participants
Start Date
Jun 8, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria4
- 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
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Interventions
DEVICECytoSorb
Application of CytoSorb treatment for 72 hours in patients with ACLF
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06079021
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