Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06079021

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

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CytoSorb

Device

Application of CytoSorb treatment for 72 hours in patients with ACLF

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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.

  2. Vasopressors

    Time frame: 24 and 72 hours

    Duration of vasopressor support in days

  3. 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

  4. 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.

  5. 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

  6. Ventilation

    Time frame: 0, 24 and 72 hours

    Duration of mechanical ventilation,

  7. 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)

  8. Mortality

    Time frame: 28, 60 and 90 days after enrolment

    Mortality at 28, 60 and 90 days after enrolment

  9. 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

  10. Cytosorb filter

    Time frame: up to 28 days after enrolment

    Adverse events attributable to CytoSorb up to 28 days after enrolment

  11. Change in Bile acids

    Time frame: 72 hours after enrolment

    Bile acids after 72 hours

  12. Sarcopenia

    Time frame: 0, 24 and 72 hours

    Prevalence and development of sarcopenia

  13. Anticoagulation

    Time frame: 0, 24 and 72 hours

    Adverse events attributable to anticoagulation

  14. 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

  15. Change in inflammatory values: lactate

    Time frame: Day 0, Day 1 and Day 3

    measurement of lactate (reference < 2 mmol/L)

  16. Change in inflammatory values: procalcitonin

    Time frame: Day 0, Day 1 and Day 3

    measurement of procalcitonin (reference < 0.5 ng/mL)

Study contacts

Contact information is provided by the study sponsor or research team.

Karolien Dams

CONTACT

[email protected]

+3238215175

Rita Jacobs

CONTACT

[email protected]

+3238214795

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • CytoSorbents Europe GmbH

Registry information

Acronym: COOLEY

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 12, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.