Acute on Chronic Liver Failure, Alcoholic Hepatitis
Conditions
Brief summary
The objective of this study is to assess the safety and performance of the CytoSorb® therapy in patients with Acute on Chronic Liver Failure (ACLF) grade ≥ 2 due to a severe alcohol induced hepatitis (Maddrey DF \> 32) and a severe inflammatory response.
Interventions
DEVICECytoSorb® 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.
Sponsors
CytoSorbents Europe GmbH
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 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
1. Platelets \< 40,000/mm3 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients in each group with Acute on Chronic Liver Failure (ACLF) grade <2 | 7 Days | To evaluate effectiveness of the CytoSorb® treatment compared to control group by comparing the proportion of patients in each group with ACLF grade \<2 at the end of Day 7 after CytoSorb® therapy start (assessed by https://www.efclif.com/scientific-activity/score-calculators/clif-c-aclf). |
| Safety of CytoSorb treatment | 30 Days | To evaluate if CytoSorb® treatment plus Standard Medical Care (SMC) compared to SMC alone is safe and tolerable as assessed by the incidence of SA(D)Es, ADEs, DDs, SADEs, and USADEs. SAE - Severe Adverse Effect; ADE - Adverse Device Effect; SADE - Severe Adverse Device Effect; DD - Device Deficiencies; USADE - Unexpected Serious Adverse Device Effect |
Countries
Germany
Outcome results
None listed