Comparing ADVOS therapy to hemodialysis for liver dysfunction patients
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
This study is testing whether a new treatment called ADVOS can help people with liver and kidney problems feel better compared to regular hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Mainz Academic / other |
| Locations | 1 site (Mainz, Rhineland-Palatinate) |
| Trial ID | NCT06129617 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of the Advanced Organ Support (ADVOS) system compared to conventional hemodialysis in eliminating protein-bound toxins in patients suffering from therapy-refractory hepatorenal syndrome. Conducted in a non-intensive care unit, the study will involve patients with acute on chronic liver failure, assessing their outcomes based on established risk stratification scores. The goal is to determine if ADVOS can provide better support for patients awaiting liver transplantation or recovery of organ function.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with acute on chronic liver failure and indications for renal replacement therapy.
Not a fit: Patients under 18, pregnant women, or those with terminal cancer or contraindications for ADVOS therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for patients with liver dysfunction and acute kidney failure.
How similar studies have performed: While there is some evidence supporting extracorporeal liver support, this specific comparison of ADVOS to hemodialysis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Mainz, Rhineland-Palatinate
- UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik — Mainz, Rhineland-Palatinate, Germany (Recruiting)
Study contacts
- Principal investigator: Julia Weinmann-Menke, Prof. — Principal Investigator
- Study coordinator: Julia Weinmann-Menke, Prof.
- Email: julia.weinmann-menke@unimedizin-mainz.de
- Phone: 0049 06131 17 2213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.