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COOLEY- Study: ACute on ChrOnic Liver FailurE Using the CYtosorb Device
RECRUITINGN/ASponsored by University Hospital, Antwerp
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Antwerp
Started2024-06-08
Est. completion2026-09-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06079021
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
Age: 18 Years+Healthy volunteers accepted
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 inclusionConditions5
Acute on Chronic Liver FailureAnticoagulant Adverse ReactionLiver DiseaseSarcopeniaUltrasonography
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Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Antwerp
Started2024-06-08
Est. completion2026-09-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06079021