A systematic review on prognostic indicators of acute on chronic liver failure and their predictive value for mortality.
Kama A Wlodzimirow, Saeid Eslami, Ameen Abu-Hanna...
https://pubmed.ncbi.nlm.nih.gov/22429562Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06079021
COOLEY- Study: Acute On Chronic Liver Failure Using the CytoSorb Device
Led by University Hospital, Antwerp · Updated on 2026-05-01
20
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Antwerp
Lead Sponsor
C
CytoSorbents Europe GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of CytoSorb hemoadsorption therapy on patients with Acute on Chronic Liver Failure (ACLF) grades 2 and 3. The study aims to evaluate changes in bilirubin and ammonia levels during treatment, as well as the development and prevalence of muscle loss (sarcopenia) using ultrasound and handgrip strength measurements. Additionally, the study compares two anticoagulation methods for patients receiving Continuous Renal Replacement Therapy (CRRT). Patients with ACLF receiving CytoSorb treatment will undergo therapy for 72 hours to help remove molecules driving systemic inflammation. The study includes a historical control group that received only standard medical care. The first group of patients on CRRT will receive Low Molecular Weight Heparin (LMWH) anticoagulation, while the second group will receive regional citrate anticoagulation (RCA), with monitoring of anti-Xa levels. Participants will be closely monitored through muscle ultrasounds, blood tests measuring bilirubin, ammonia, bile acids, and inflammatory markers, as well as clinical assessments including hepatic encephalopathy grading, hemodynamic profiles, and renal function. Outcome measures will be recorded at various time points up to 90 days after enrollment. The study also tracks mortality and ventilation status, aiming to better understand treatment effects and muscle status in this critically ill group.
CONDITIONS
Brief Title
COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older admitted to the University Hospital of Antwerp
- Written informed consent from the patient or legal representative if the patient has encephalopathy above grade 2
- Diagnosis of acute-on-chronic liver failure grade 2 or higher
- Presence of an acute decompensation event with an identifiable trigger
- Hepatic encephalopathy grade 2 or higher
- Acute kidney injury stage 3 according to KDIGO criteria
- Serum bilirubin level of 10 mg/dl or higher
- Hemodynamic instability requiring vasopressor support with norepinephrine above 0.05 mcg/kg/min
You will not qualify if you...
- Known refusal by the patient to participate or against study measures
- Decision made to stop further treatment within 24 hours before inclusion
- No complete remission of cancer, including hepatocellular carcinoma, within the past 12 months
- Ongoing intermittent or continuous renal replacement therapy before study inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 72 hours
Participants with acute on chronic liver failure receive CytoSorb hemoadsorption treatment for 72 hours to remove molecules driving systemic inflammation.
Daily visits during treatment period
Follow-up
Duration - Up to 90 days after treatment
Participants are monitored for changes in liver function, renal function, inflammation, and survival over several weeks and months after treatment.
Visits at Day 7, 14, 21, 28, 60, and 90
Trial Site Locations
Total: 1 location
1
UZA
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
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Research Team
K
Karolien Dams
R
Rita Jacobs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Artificial Liver Support with CytoSorb and MARS in Liver Failure: A Retrospective Propensity Matched Analysis.
Mihai Popescu, Corina David, Alexandra Marcu...
https://pubmed.ncbi.nlm.nih.gov/36983259Assessment of Malnutrition, Sarcopenia and Frailty in Patients with Cirrhosis: Which Tools Should We Use in Clinical Practice?
Benjamin Buchard, Yves Boirie, Lucie Cassagnes...
https://pubmed.ncbi.nlm.nih.gov/31936597Reference equations for handgrip strength: Normative values in young adult and middle-aged subjects.
Jordão Lopes, Samantha Torres Grams, Edy Floriano da Silva...
https://pubmed.ncbi.nlm.nih.gov/28389120Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: Is Metabolic Fear the Enemy of Logic? A Systematic Review and Meta-Analysis of Randomised Controlled Trials.
Rita Jacobs, Walter Verbrugghe, Karolien Dams...
https://pubmed.ncbi.nlm.nih.gov/37240843