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)

UZA

Edegem, Antwerp, Belgium

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NCT06079021


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