Status:
RECRUITING
Intermittent ADVOS vs. Hemodialysis in Non-intensive Care Patients With Liver Dysfunction
Lead Sponsor:
University Medical Center Mainz
Collaborating Sponsors:
ADVITOS GmbH München
Conditions:
Liver Cirrhosis
Kidney Failure, Acute
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In the planned randomized controlled prospective pilot study, we aim to evaluate ADVOS compared with conventional hemodialysis regarding the elimination of protein-bound toxins in patients with therap...
Detailed Description
Acute on chronic liver failure (ACLF) is a syndrome in patients with liver cirrhosis characterized by acute hepatic decompensation (i.e., jaundice, ascites, hepatic encephalopathy, bacterial infection...
Eligibility Criteria
Inclusion
- Capacity of the patient to give consent
- Pre-existing liver disease in the sense of an ACLF with HRS
- Age \>18 years
- Patient of the University Medical Center Mainz
- Bilirubin level ≥ 4 mg/dl
- Indication for renal replacement procedure is based on STARRT-AKI criteria (serum potassium ≥ 6 mmol/l in two independent blood samples; serum pH of 7.2 or less or serum bicarbonate of 12 mmol/l or less; respiratory failure secondary to volume excess)
Exclusion
- Age \< 18 years
- Pregnancy
- Contraindications for ADVOS therapy
- Already started renal replacement therapy
- Contraindication for citrate anticoagulation
- Use of vasopressors and MAD ≤ 50 mmHg.
- Terminal cancer
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06129617
Start Date
June 1 2023
End Date
June 1 2026
Last Update
November 13 2023
Active Locations (1)
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1
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik
Mainz, Rhineland-Palatinate, Germany, 55130