CytoSorb® in Patients With Acute on Chronic Liver Failure
NCT ID: NCT05131230
Last Updated: 2022-11-29
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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WITHDRAWN
OBSERVATIONAL
2022-03-15
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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CytoSorb group
CytoSorb® treatment
Patients with Acute on Chronic Liver Failure (ACLF) due to Severe Alcoholic Hepatitis in combination with systemic inflammation and ACLF grade ≥2 will be enrolled in this study. Every patient that is screened, fulfills the inclusion/exclusion criteria, and consents to the study, will be allowed to enter the study. Patients will receive Standard of Care treatment for alcoholic hepatitis plus treatment with the CytoSorb® 300 mL device.
Interventions
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CytoSorb® treatment
Patients with Acute on Chronic Liver Failure (ACLF) due to Severe Alcoholic Hepatitis in combination with systemic inflammation and ACLF grade ≥2 will be enrolled in this study. Every patient that is screened, fulfills the inclusion/exclusion criteria, and consents to the study, will be allowed to enter the study. Patients will receive Standard of Care treatment for alcoholic hepatitis plus treatment with the CytoSorb® 300 mL device.
Eligibility Criteria
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Inclusion Criteria
2. Signed Informed Consent Form (ICF)
3. Total bilirubin ≥ 8 mg/dL
4. Acute Alcoholic Hepatitis diagnosed by EtOH consumption within 6 weeks of onset of symptoms, exclusion of other causes for jaundice and liver biopsy or at least 2 out of the following symptoms:
* Hepatomegaly
* AST \> ALT
* Elevated WBC
* Ascites
5. Maddrey DF \> 32
6. Systemic inflammation as defined by 2 fulfilled criteria out of:
* leucocytosis
* body temperature \> 38°C
* tachycardia \> 90 bpm
* tachypnoeia \> 20 breaths/min
7. ACLF grade ≥2
8. Creatinine \>2 mg/dl and increase \>1.5 mg/dl despite standard of care
Exclusion Criteria
2. INR \> 3.5
3. MELD Score \> 35
4. AST \> 500 IU/l
5. Bilirubin reduction \> 20% in prior 72 hours (early responders to conventional Standard of Care (SOC))
6. Uncontrolled infection, bleeding or hemodynamic instability
7. Small liver size (diagnosed by imaging, ultrasound/CT)
8. Chronic dialysis
9. Contraindications for CytoSorb® according to Instructions for Use
10. ACLF grade \<2
18 Years
ALL
No
Sponsors
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CytoSorbents Europe GmbH
INDUSTRY
Responsible Party
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Locations
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Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
Bochum, , Germany
University of Rostock
Rostock, , Germany
Countries
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Other Identifiers
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L02HOF
Identifier Type: -
Identifier Source: org_study_id
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