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

NCT06079021 | Recruiting

• 1 other identifier: Edge 2930
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

acute on chronic liver failure; sarcopenia; citrate anticoagulation; low molecular weight heparins; hand grip strength; skeletal muscle ultrasound; hemoadsorption; CRRT

Outcome Measures

Primary Outcomes (2)

• The impact of CytoSorb on serum bilirubin removal

  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

  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 Outcomes (16)

• changes in hemodynamic profile

  24 and 72 hours

• Vasopressors

  24 and 72 hours

• ACLF (Acute on Chronic Liver Failure) Grading

  first week

• SOFA Score

  0, 72 and 168 hours

• scores

  15 days

Study Arms (2)

CytoSorb hemoadsorption

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

Historical group that received only standard medical care

Interventions

CytoSorb DEVICE

Application of CytoSorb treatment for 72 hours in patients with ACLF

CytoSorb hemoadsorption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• known patient will against participation in the study or against the measures applied in the study
• no complete remission of malignancy including hepatocellular carcinoma within the past 12 months

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• CytoSorbents Europe GmbH: collaborator

Study Sites (1)

UZA

Edegem, Antwerp, 2650, Belgium

RECRUITING

Related Publications (5)

• 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.

  PMID: 22429562 RESULT

• 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.

  PMID: 36983259 RESULT

• 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.

  PMID: 31936597 RESULT

• 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.

  PMID: 28389120 RESULT

• 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.

  PMID: 37240843 RESULT

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Sarcopenia

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Karolien Dams

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolien Dams

CONTACT

+3238215175; Karolien.Dams@uza.be

Rita Jacobs

CONTACT

+3238214795; rita.jacobs2@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, senior staff intensive care

Model Details: Application of CytoSorb treatment to ACLF patients

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: October 12, 2023
• Study Start: June 8, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

BE (1)