COOLEY- Study: ACute on ChrOnic Liver FailurE Using the CYtosorb Device

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Belgium
UZA
RECRUITING
Edegem
Contact Information
Primary
Karolien Dams
Karolien.Dams@uza.be
+3238215175
Backup
Rita Jacobs
rita.jacobs2@uza.be
+3238214795
Time Frame
Start Date: 2024-06-08
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 20
Treatments
Active_comparator: CytoSorb hemoadsorption
Patients with acute on chronic liver failure will receive CytoSorb treatment for 72 hours. The aim is to remove the molecules that drive systemic inflammation.
No_intervention: Control group
Historical group that received only standard medical care
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Antwerp
Collaborators: CytoSorbents Europe GmbH

This content was sourced from clinicaltrials.gov