Liver CirrhosisADVOMITTENTNCT06129617
Intermittent ADVOS vs. Hemodialysis in Non-intensive Care Patients With Liver Dysfunction
A study testing Hemodialysis and ADVOS in people with Liver Cirrhosis and Kidney Failure, Acute, run by University Medical Center Mainz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Kidney Failure, Acute, Kidney Replacement
- What is being tested?
- Hemodialysis and ADVOS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik
Mainz, Rhineland-Palatinate, 55130
Julia Weinmann-Menke, Prof. Dr., 00496131/172462, julia.weinmann-menke@unimedizin-mainz.de
Simone Cosima Boedecker, Dr., 00496131/172213, SimoneCosima.Boedecker@unimedizin-mainz.de
About this study
Official title: 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
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.
Read the 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, or gastrointestinal bleeding) and single or multi-organ failure, resulting in increased mortality. The European Association for the Study of the Liver (EASL) has established the Chronic Liver Failure (CLIF) consortium, which has developed a score for risk stratification and prognosis estimation, the CLIF-C ACLF score. Based on the CANONIC study, the CLIF consortium has developed a simplified CLIF Consortium Organ Failure Score (CLIF-C OFs), which includes liver, kidney, and lung function, hepatic encephalopathy, coagulation, and hemodynamics. Considering two other mortality factors (age and leukocyte count), the CLIF-C ACLF score was defined. The score has a higher predictive value for 28- and 90-day mortality than the Model of End Stage Liver Disease (MELD), MELD-Na, or Child-Turcotte-Pugh score.
Therapeutic options are limited and aim to address specific organ complications. In most cases, due to progressive renal insufficiency as part of hepatorenal syndrome, renal replacement therapy is if indicated. The only potential cure is liver transplantation.
There is some evidence that extracorporeal liver support can help a patient until liver transplantation or restoration of organ function. The Advanced Organ Support (ADVOS) system (ADVITOS GmbH, Munich, Germany) is an albumin-based advanced hemodialysis procedure, which can support the liver. The principles of conventional renal replacement therapy for the elimination of water-soluble substances are combined with the elimination of protein-bound substances by recirculating a dialysate containing 200 ml of human albumin. This procedure is typically used as continuous treatment in an intensive care setting. However, the investigators have already investigated the possibility of ADVOS as an intermittent procedure in patients with ACLF on a regular ward in a retrospective study.
To the best of knowledge of the investigators, there are currently no randomized studies comparing the elimination of protein-bound toxins between ADVOS and hemodialysis. Nevertheless, based on the investigators clinical experience, the investigators hypothesize that treatment with ADVOS may confer advantages over hemodialysis. Therefore, the objective of this study is to assess the effectiveness of ADVOS in comparison to hemodialysis for the treatment of patients with therapy-refractory hepatorenal syndrome.
- Being tested
- Hemodialysis, ADVOS
- Medical subject headings
- Liver Cirrhosis, Acute Kidney Injury, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodialysisDevice
5 treatments with hemodialysis on day 1, 2, 3, 5 and 7
ADVOSDevice
5 treatments with ADVOS on day 1, 2, 3, 5 and 7
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis | Active comparator | Patients receiving hemodialysis therapy mit Fresenius 5008 Receives: Device: Hemodialysis |
| ADVOS | Experimental | Patients receiving ADVOS therapy with ADVOS multi Receives: Device: ADVOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
course of total bilirubin in patients blood
measurement of concentration of total bilirubin in serum of patients in mg/dl
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
Secondary outcomes (22)
course of uremia toxins in patients blood
measurement of blood urea nitrogen in serum of patients in mg/dl
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of bile acids
measurement of bile acids in serum of patients in mg/dl
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
evaluation of safety of ADVOS versus hemodialysis
Rate of complications during procedure (for example hypotension, electrolyte disorders etc.)
Measured: during the five interventions
Quality of life raised in a standardized questionnaire
We will use the WHOQOL-BREF-questionnaire with 26 questions and values from 1 to 5; 1 being the lowes value and 5 the highest value
Measured: baseline before intervention and on days 28, 90, 180
number of days in hospital during the intervention
we will measure the number of days in the hospital during the intervention from admission to our department until discharge from our department
Measured: admission in our department till discharge from our deparment
course of pO2
we will measure the pO2 (in mmHg) in a blood sample with blood gas system (ABL800 FLEX Plus)
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of pCO2
we will measure the pCO2 (in mmHg) in a blood sample with blood gas system (ABL800 FLEX Plus)
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of base excess
we will measure the base excess (mmol/l) in a blood sample with blood gas system (ABL800 FLEX Plus)
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of pH
we will measure the pH in a blood sample with blood gas system (ABL800 FLEX Plus)
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of standard bicarbonat concentration
we will measure the standard bicarbonat concentration (mmol/l) in a blood sample with blood gas system (ABL800 FLEX Plus)
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of potassium
we will measure the potassium (mmol/l) in a blood sample with blood gas system (ABL800 FLEX Plus)
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of sodium
we will measure the sodium (mmol/l) in a blood sample with blood gas system (ABL800 FLEX Plus)
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of ionised calcium
we will measure the ionised calcium (mmol/l) in a blood sample with blood gas system (ABL800 FLEX Plus)
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of bilirubin
we will measure the bilirubin (in mg/dl) in a blood sample
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of INR
we will measure the INR in a blood sample
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of albumin
we will measure the albumin (in g/l) in a blood sample
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of kidney function
we will measure the kreatinine (in mg/dl) in a blood sample
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
course of MELD
MELD = Model for End-stage Liver Disease (6-40, Higher numbers indicate increased mortality)
Measured: Within 6 hours before first treatment and within 2 hours after 5 treatments
course of CLIF-C ACLF score
CLIF-C ACLF Score = Chronich Liver failure Consortium acute on chronic liver failure score (6-15, higher numbers indicate increased mortality)
Measured: Within 6 hours before first treatment and within 2 hours after 5 treatments
course of hepatic encephalopathy
an experienced clinician will determine the grade of the hepatic encephalopathy using the west haven criteria (grade 1 till grade 4, "grade 1" beeing the lowest value und "grade 4" beeing the highest value)
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
mortality
Measured: 28, 90 and 180 days.
elimination of blood urea nitrogen
We will measure the Blood urea nitrogen (mg/dl) in a blood sample
Measured: Within 6 hours before first treatment and within 2 hours after every treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- ADVITOS GmbH München
- Responsible party
- Principal investigator, Prof. Dr. Julia Weinmann-Menke, University Medical Center Mainz
- Investigators
- Julia Weinmann-Menke, Prof., Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129617
- Sponsor's protocol ID
- ADVOMITTENT
- Acronym
- ADVOMITTENT
- Status last verified
- Nov 2023
- First submitted
- 21 Jun 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06129617
- Acronym / sponsor ID
- ADVOMITTENT / ADVOMITTENT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University Medical Center MainzUniversity, hospital or other
- Collaborators
- ADVITOS GmbH München
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, or gastrointestinal bleeding) and single or multi-organ failure, resulting in increased mortality. The European Association for the Study of the Liver (EASL) has established the Chronic Liver Failure (CLIF) consortium, which has developed a score for risk stratification and prognosis estimation, the CLIF-C ACLF score. Based on the CANONIC study, the CLIF consortium has developed a simplified CLIF Consortium Organ Failure Score (CLIF-C OFs), which includes liver, kidney, and lung function, hepatic encephalopathy, coagulation, and hemodynamics. Considering two other mortality factors (age and leukocyte count), the CLIF-C ACLF score was defined. The score has a higher predictive value for 28- and 90-day mortality than the Model of End Stage Liver Disease (MELD), MELD-Na, or Child-Turcotte-Pugh score.
Therapeutic options are limited and aim to address specific organ complications. In most cases, due to progressive renal insufficiency as part of hepatorenal syndrome, renal replacement therapy is if indicated. The only potential cure is liver transplantation.
There is some evidence that extracorporeal liver support can help a patient until liver transplantation or restoration of organ function. The Advanced Organ Support (ADVOS) system (ADVITOS GmbH, Munich, Germany) is an albumin-based advanced hemodialysis procedure, which can support the liver. The principles of conventional renal replacement therapy for the elimination of water-soluble substances are combined with the elimination of protein-bound substances by recirculating a dialysate containing 200 ml of human albumin. This procedure is typically used as continuous treatment in an intensive care setting. However, the investigators have already investigated the possibility of ADVOS as an intermittent procedure in patients with ACLF on a regular ward in a retrospective study.
To the best of knowledge of the investigators, there are currently no randomized studies comparing the elimination of protein-bound toxins between ADVOS and hemodialysis. Nevertheless, based on the investigators clinical experience, the investigators hypothesize that treatment with ADVOS may confer advantages over hemodialysis. Therefore, the objective of this study is to assess the effectiveness of ADVOS in comparison to hemodialysis for the treatment of patients with therapy-refractory hepatorenal syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis | Active comparator | Device: HemodialysisPatients receiving hemodialysis therapy mit Fresenius 5008 |
| ADVOS | Experimental | Device: ADVOSPatients receiving ADVOS therapy with ADVOS multi |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Age < 18 years
- Pregnancy
- Contraindications for ADVOS therapy
- Already started renal replacement therapy
- Contraindication for citrate anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodialysis5 treatments with hemodialysis on day 1, 2, 3, 5 and 7 | Device | Hemodialysis |
| ADVOS5 treatments with ADVOS on day 1, 2, 3, 5 and 7 | Device | ADVOS |
Primary outcome
course of total bilirubin in patients blood
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
measurement of concentration of total bilirubin in serum of patients in mg/dl
22 secondary outcomes
course of uremia toxins in patients blood
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of bile acids
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
evaluation of safety of ADVOS versus hemodialysis
Time frame: during the five interventions
Quality of life raised in a standardized questionnaire
Time frame: baseline before intervention and on days 28, 90, 180
number of days in hospital during the intervention
Time frame: admission in our department till discharge from our deparment
course of pO2
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of pCO2
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of base excess
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of pH
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of standard bicarbonat concentration
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of potassium
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of sodium
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of ionised calcium
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of bilirubin
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of INR
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of albumin
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of kidney function
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of MELD
Time frame: Within 6 hours before first treatment and within 2 hours after 5 treatments
course of CLIF-C ACLF score
Time frame: Within 6 hours before first treatment and within 2 hours after 5 treatments
course of hepatic encephalopathy
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
mortality
Time frame: 28, 90 and 180 days.
elimination of blood urea nitrogen
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Weinmann-Menke, Prof. principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis and ADVOS in people with Liver Cirrhosis and Kidney Failure, Acute, run by University Medical Center Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Weinmann-Menke, Prof. (0049 06131 17 2213, julia.weinmann-menke@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
course of total bilirubin in patients blood (time frame: Within 6 hours before first treatment and within 2 hours after every treatment session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.