COOLEY- Study: ACute on ChrOnic Liver FailurE Using the CYtosorb Device
NCT ID: NCT06079021
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-06-08
2027-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
CytoSorb
Application of CytoSorb treatment for 72 hours in patients with ACLF
Control group
Historical group that received only standard medical care
No interventions assigned to this group
Interventions
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CytoSorb
Application of CytoSorb treatment for 72 hours in patients with ACLF
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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CytoSorbents Europe GmbH
INDUSTRY
University Hospital, Antwerp
OTHER
Responsible Party
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Karolien Dams
Principal Investigator, MD, senior staff intensive care
Principal Investigators
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Karolien Dams
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
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UZA
Edegem, Antwerp, Belgium
Countries
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Central Contacts
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Facility Contacts
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Karolien Dams, MD
Role: primary
Rita Jacobs, MD
Role: backup
References
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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.
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.
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.
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.
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.
Other Identifiers
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Edge 2930
Identifier Type: -
Identifier Source: org_study_id