Cytokine Adsorption in Acute-on-chronic Liver Failure
NCT05019352 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2021-11-02
Summary
The CYTOHEP study is a prospective, randomized, single center, open-label, controlled intervention trial to assess the benefit of extracorporeal hemoadsorption using the CytoSorb device in patients with acute-on-chronic liver failure. The primary goal for this trial is to assess whether the CytoSorb device used in addition to continuous renal replacement therapy (CRRT) will be able to significantly reduce bilirubin in the patient blood as compared to the control group treated with CRRT alone (i.e., without extracorporeal hemoadsorption).
The rationale for this study is based on considerations about the role of systemic inflammation in acute decompensation of liver cirrhosis and ACLF, in-vitro data of the effectiveness CytoSorb for the removal of molecules with a pathophysiological role in acute-on-chronic liver failure, and recent reports on the successful use of extracorporeal hemoadsorption in combination with CRRT in critically ill patients with acute liver dysfunction.
Conditions
- Acute-On-Chronic Liver Failure
- Renal Failure
Interventions
- DEVICE
-
CytoSorb cytokine adsorber
device for extracorporeal hemoadsorption
- DEVICE
-
CRRT
continuous renal replacement therapy
Sponsors & Collaborators
-
Dr. Alexander Supady
lead OTHER
Principal Investigators
-
Alexander Supady, MD, MPH · University Hospital Freiburg
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-25
- Primary Completion
- 2022-12-31
- Completion
- 2023-01-30
Countries
- Germany
Study Locations
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