COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 decompensation event (identifiable trigger)
Hepatic encephalopathy grade ≥ 2
Disqualifiers
• 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
Trial design
Design model
Parallel
Treatments tested in this trial
CytoSorb
DeviceApplication of CytoSorb treatment for 72 hours in patients with ACLF
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: CytoSorb hemoadsorptionActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The impact of CytoSorb on serum bilirubin removal
20 participants with a serum bilirubin of ≥ 10 mg/dl will undergo CytoSorb for 72 hours
Time frame
24 and 72 hours2
Changes in ammonia and severity of hepatic encephalopathy during treatment period
The West Haven criteria are used for grading the severity of hepatic encephalopathy, which include 5 grades ranging from minimal (slightly impaired) to grade IV (comatose)
Time frame
24 and 72 hoursSecondary outcomes
1
changes in hemodynamic profile
Change in hemodynamic profile (i.e. mean arterial pressure normalized to norepinephrine equivalents) during the 72-h study intervention.
Time frame
24 and 72 hours2
Vasopressors
Duration of vasopressor support in days
Time frame
24 and 72 hours3
ACLF (Acute on Chronic Liver Failure) Grading
Assessment of ACLF grading (minimum 0 - maximum 3; higher score means a worse outcome) during the 72h intervention up to 1 week after diagnosis of ACLF
Time frame
first week4
SOFA Score
Changes in Sequential Organ Failure Assessment (SOFA) (minimum 0-maximum 24; higher score means a worse outcome) score during the 72h study period and up to 1 week after.
Time frame
0, 72 and 168 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Antwerp
Lead sponsor
CytoSorbents Europe GmbH
Collaborator
Source ClinicalTrials.gov