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Recruiting NCT06079021

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

No phase Interventional Acute-On-Chronic Liver Failure Anticoagulant Adverse Reaction Sarcopenia Ultrasonography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CytoSorb.
Who it may be relevant to
Registry conditions: Acute-On-Chronic Liver Failure, Anticoagulant Adverse Reaction, Sarcopenia, Ultrasonography. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • Device CytoSorb
    Application of CytoSorb treatment for 72 hours in patients with ACLF

Primary outcome measures

  • The impact of CytoSorb on serum bilirubin removal [Time frame: 24 and 72 hours]
  • Changes in ammonia and severity of hepatic encephalopathy during treatment period [Time frame: 24 and 72 hours]
Secondary outcome measures (12)
  • changes in hemodynamic profile [Time frame: 24 and 72 hours]
  • Vasopressors [Time frame: 24 and 72 hours]
  • ACLF (Acute on Chronic Liver Failure) Grading [Time frame: first week]
  • SOFA Score [Time frame: 0, 72 and 168 hours]
  • scores [Time frame: 15 days]
  • Ventilation [Time frame: 0, 24 and 72 hours]
  • Cytokines [Time frame: 0, 24 and 72 hours]
  • Mortality [Time frame: 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]
  • Cytosorb filter [Time frame: up to 28 days after enrolment]
  • Change in Bile acids [Time frame: 72 hours after enrolment]
  • Sarcopenia [Time frame: 0, 24 and 72 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • UZA — Edegem

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 37240843

Identifiers

NCT: NCT06079021 · Edge 2930

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗