COOLEY- Study: ACute on ChrOnic Liver FailurE Using the CYtosorb Device

Antwerp University Hospital (UZA)

Status: Enrolling

Conditions: Acute-On-Chronic Liver Failure; Anticoagulant Adverse Reaction; Ultrasonography; Sarcopenia

Treatments: Device: CytoSorb

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06079021

Edge 2930

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

CytoSorb hemoadsorption

Active Comparator group

Description:

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.

Treatment:

Device: CytoSorb

Control group

No Intervention group

Description:

Historical group that received only standard medical care