COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device (NCT06079021) | Clinical Trial Compass
RecruitingNot Applicable
COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device
Belgium20 participantsStarted 2024-06-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The impact of CytoSorb on serum bilirubin removal
Timeframe: 24 and 72 hours
2
Changes in ammonia and severity of hepatic encephalopathy during treatment period