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

April 27, 2026 updated by: Karolien Dams, University Hospital, Antwerp
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: CytoSorb
Application of CytoSorb treatment for 72 hours in patients with ACLF
No Intervention: Control group
Historical group that received only standard medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of CytoSorb on serum bilirubin removal
Time Frame: 24 and 72 hours
20 participants with a serum bilirubin of ≥ 10 mg/dl will undergo CytoSorb for 72 hours
24 and 72 hours
Changes in ammonia and severity of hepatic encephalopathy during treatment period
Time Frame: 24 and 72 hours
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)
24 and 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in hemodynamic profile
Time Frame: 24 and 72 hours
Change in hemodynamic profile (i.e. mean arterial pressure normalized to norepinephrine equivalents) during the 72-h study intervention.
24 and 72 hours
Vasopressors
Time Frame: 24 and 72 hours
Duration of vasopressor support in days
24 and 72 hours
ACLF (Acute on Chronic Liver Failure) Grading
Time Frame: first week
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
first week
SOFA Score
Time Frame: 0, 72 and 168 hours
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.
0, 72 and 168 hours
scores
Time Frame: 15 days
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
15 days
Ventilation
Time Frame: 0, 24 and 72 hours
Duration of mechanical ventilation,
0, 24 and 72 hours
Cytokines
Time Frame: 0, 24 and 72 hours
Changes in cytokines (IL-6, IL-8, IL-16, TNF (tumor necrosis factor)-alpha) value (pg/ml)
0, 24 and 72 hours
Mortality
Time Frame: 28, 60 and 90 days after enrolment
Mortality at 28, 60 and 90 days after enrolment
28, 60 and 90 days after enrolment
Improvement of Renal function after application of CytoSorb
Time Frame: 7, 14, 21 and 90 days after enrolment
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
7, 14, 21 and 90 days after enrolment
Cytosorb filter
Time Frame: up to 28 days after enrolment
Adverse events attributable to CytoSorb up to 28 days after enrolment
up to 28 days after enrolment
Change in Bile acids
Time Frame: 72 hours after enrolment
Bile acids after 72 hours
72 hours after enrolment
Sarcopenia
Time Frame: 0, 24 and 72 hours
Prevalence and development of sarcopenia
0, 24 and 72 hours
Anticoagulation
Time Frame: 0, 24 and 72 hours
Adverse events attributable to anticoagulation
0, 24 and 72 hours
SAPS II score
Time Frame: Day 0, Day 3, Day 7
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
Day 0, Day 3, Day 7
Change in inflammatory values: lactate
Time Frame: Day 0, Day 1 and Day 3
measurement of lactate (reference < 2 mmol/L)
Day 0, Day 1 and Day 3
Change in inflammatory values: procalcitonin
Time Frame: Day 0, Day 1 and Day 3
measurement of procalcitonin (reference < 0.5 ng/mL)
Day 0, Day 1 and Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

CytoSorbents Europe GmbH

Investigators

  • Principal Investigator: Karolien Dams, University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Edge 2930

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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