Intermittent ADVOS vs. Hemodialysis in Non-intensive Care Patients With Liver Dysfunction (NCT06129617) | Clinical Trial Compass
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Intermittent ADVOS vs. Hemodialysis in Non-intensive Care Patients With Liver Dysfunction
Germany14 participantsStarted 2023-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
course of total bilirubin in patients blood
Timeframe: Within 6 hours before first treatment and within 2 hours after every treatment session