Intermittent ADVOS vs. Hemodialysis in Non-intensive Care Patients With Liver Dysfunction
Prospective Randomized Controlled Trial for Protein-bound Toxins Removal With Intermittent ADVOS vs. Hemodialysis Treatment in Non-intensive Care Patients With Pre-existing Liver Dysfunction and Indication for Extracorporeal Renal Support. The ADVOMITTENT Study
University Medical Center Mainz
14 participants
Jun 1, 2023
INTERVENTIONAL
Conditions
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 therapy-refractory hepatorenal syndrome. The study will be performed in a regular non-ICU ward with a large experience in the use of the ADVOS therapy.
Eligibility
Inclusion Criteria6
- 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 Criteria7
- 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
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Interventions
5 treatments with hemodialysis on day 1, 2, 3, 5 and 7
5 treatments with ADVOS on day 1, 2, 3, 5 and 7
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06129617