AzTrials
AzTrials

Acute-On-Chronic Liver FailureCOOLEYNCT06079021

COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device

A study testing CytoSorb in people with Acute-On-Chronic Liver Failure and Anticoagulant Adverse Reaction, run by University Hospital, Antwerp at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CytoSorb
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBelgium
Study dates
8 Jun 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Karolien Dams contact

+3238215175

Karolien.Dams@uza.be

Rita Jacobs contact

+3238214795

rita.jacobs2@uza.be

Belgium1 site, 1 recruiting

  • UZA

    Edegem, Antwerp, 2650

    Karolien Dams, MD, +3238215175, Karolien.Dams@uza.be

    Rita Jacobs, MD, +3238214795, rita.jacobs2@uza.be

    Recruiting

Other trials in Belgium

About this study

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.

Read the detailed description

The study team wants to investigate the effect of Cytosorb hemoadsorption on the bilirubin level as well as on the ammonia level changes induced by the therapy in patients with Acute on Chronic Liver Failure (ACLF) .

In this group of patients with ACLF grade 2 and 3 the investigators want to determine the prevalence and development of sarcopenia by sequential quadriceps and thenar ultrasound images and by handgrip strength measurement.

The investigators will objectify muscle mass by skeletal muscle ultrasound of quadriceps and thenar muscles in this sickest subgroup of cirrhotic patients. Ultrasound forms a part of the daily clinical routine in ICU. The study team wants to compare both measurements and objectify the evolution to study the reliability and validity of ultrasound to quantify muscles in chronic liver disease and its clinical values. Most of ultrasonographic studies are based on quadriceps exploration, which is more inconvenient and takes more time than exploring the hands because patients need to remove clothes and lie down. The study team also hypothesizes that thenar muscles are less subject to fluid overload than the quadriceps muscles are.

When available, lumbar skeletal muscle indices will be compared by computed tomography or magnetic resonance imaging.

In this group of patients with ACLF, receiving Continuous Renal Replacement Therapy (CRRT) the appropriate choice of anticoagulant remains controversial. The objective of this study is to compare the efficacy and safety of regional citrate anticoagulation (RCA) and Low Molecular Weight Heparin (LMWH) in critically ill ACLF patients requiring CRRT. These two commercially available anticoagulation methods are used in daily practice in the ICU. The first 10 patients will receive anticoagulation with LMWH with monitoring of anti-Xa. The second cohort of patients will receive RCA.

Being tested
CytoSorb
Keywords
acute on chronic liver failure, sarcopenia, citrate anticoagulation, low molecular weight heparins, hand grip strength, skeletal muscle ultrasound, hemoadsorption, CRRT
Medical subject headings
Acute-On-Chronic Liver Failure, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CytoSorbDevice

    Application of CytoSorb treatment for 72 hours in patients with ACLF

Study groups in NCT06079021
Study groupRoleWhat they receive
CytoSorb hemoadsorptionActive comparatorPatients with acute on chronic liver failure will receive CytoSorb treatment for 72 hours. The aim is to remove the molecules that drive systemic inflammation.
Receives: Device: CytoSorb
Control groupNo interventionHistorical group that received only standard medical care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 and 72 hours

  2. 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)

    Measured: 24 and 72 hours

Secondary outcomes (16)

  1. changes in hemodynamic profile

    Change in hemodynamic profile (i.e. mean arterial pressure normalized to norepinephrine equivalents) during the 72-h study intervention.

    Measured: 24 and 72 hours

  2. Vasopressors

    Duration of vasopressor support in days

    Measured: 24 and 72 hours

  3. 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

    Measured: first week

  4. 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.

    Measured: 0, 72 and 168 hours

  5. scores

    Changes in CLIF-C (Chronic Liver Failure Consortium)(minimu 0 - maximum 100; higher score means a worse outcome) score during the 72-h intervention, up to 15 days after diagnosis of ACLF

    Measured: 15 days

  6. Ventilation

    Duration of mechanical ventilation,

    Measured: 0, 24 and 72 hours

  7. Cytokines

    Changes in cytokines (IL-6, IL-8, IL-16, TNF (tumor necrosis factor)-alpha) value (pg/ml)

    Measured: 0, 24 and 72 hours

  8. Mortality

    Mortality at 28, 60 and 90 days after enrolment

    Measured: 28, 60 and 90 days after enrolment

  9. Improvement of Renal function after application of CytoSorb

    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) will receive CytoSorb treatmetn. Serum creatinine will be measured at day 7, 14, 21 and 90 days

    Measured: 7, 14, 21 and 90 days after enrolment

  10. Cytosorb filter

    Adverse events attributable to CytoSorb up to 28 days after enrolment

    Measured: up to 28 days after enrolment

  11. Change in Bile acids

    Bile acids after 72 hours

    Measured: 72 hours after enrolment

  12. Sarcopenia

    Prevalence and development of sarcopenia

    Measured: 0, 24 and 72 hours

  13. Anticoagulation

    Adverse events attributable to anticoagulation

    Measured: 0, 24 and 72 hours

  14. SAPS II score

    Simplified Acute Physiology Score II (SAPS II) (minimum 0 - maximum 163; higher score means a worse outcome) during the 72-h study intervention and up to 1 week after

    Measured: Day 0, Day 3, Day 7

  15. Change in inflammatory values: lactate

    measurement of lactate (reference < 2 mmol/L)

    Measured: Day 0, Day 1 and Day 3

  16. Change in inflammatory values: procalcitonin

    measurement of procalcitonin (reference < 0.5 ng/mL)

    Measured: Day 0, Day 1 and Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start8 Jun 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Application of CytoSorb treatment to ACLF patients
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06079021
Sponsor's protocol ID
Edge 2930
Acronym
COOLEY
Status last verified
Apr 2026
First submitted
26 Jul 2023
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wlodzimirow KA, Eslami S, Abu-Hanna A, Nieuwoudt M, Chamuleau RA. A systematic review on prognostic indicators of acute on chronic liver failure and their predictive value for mortality. Liver Int. 2013 Jan;33(1):40-52. doi: 10.1111/j.1478-3231.2012.02790.x. Epub 2012 Mar 19.

    PubMed 22429562

  • Popescu M, David C, Marcu A, Olita MR, Mihaila M, Tomescu D. Artificial Liver Support with CytoSorb and MARS in Liver Failure: A Retrospective Propensity Matched Analysis. J Clin Med. 2023 Mar 14;12(6):2258. doi: 10.3390/jcm12062258.

    PubMed 36983259

  • Buchard B, Boirie Y, Cassagnes L, Lamblin G, Coilly A, Abergel A. Assessment of Malnutrition, Sarcopenia and Frailty in Patients with Cirrhosis: Which Tools Should We Use in Clinical Practice? Nutrients. 2020 Jan 9;12(1):186. doi: 10.3390/nu12010186.

    PubMed 31936597

  • Lopes J, Grams ST, da Silva EF, de Medeiros LA, de Brito CMM, Yamaguti WP. Reference equations for handgrip strength: Normative values in young adult and middle-aged subjects. Clin Nutr. 2018 Jun;37(3):914-918. doi: 10.1016/j.clnu.2017.03.018. Epub 2017 Mar 24.

    PubMed 28389120

  • Jacobs R, Verbrugghe W, Dams K, Roelant E, Couttenye MM, Devroey D, Jorens P. Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: Is Metabolic Fear the Enemy of Logic? A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Life (Basel). 2023 May 17;13(5):1198. doi: 10.3390/life13051198.

    PubMed 37240843

Questions about this trial

What is this clinical trial studying?

A study testing CytoSorb in people with Acute-On-Chronic Liver Failure and Anticoagulant Adverse Reaction, run by University Hospital, Antwerp at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karolien Dams (+3238215175, Karolien.Dams@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The impact of CytoSorb on serum bilirubin removal (time frame: 24 and 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06079021, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in