An interventional study of Hemodialysis and ADVOS in Liver Cirrhosis, Kidney Failure, Acute and Kidney Replacement, sponsored by University Medical Center Mainz. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by University Medical Center Mainz · Not applicable, Interventional, and Treatment
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.
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.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 14 is below the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University Medical Center Mainz is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving hemodialysis therapy mit Fresenius 5008
Device: Hemodialysis
Patients receiving ADVOS therapy with ADVOS multi
Device: ADVOS
5 treatments with hemodialysis on day 1, 2, 3, 5 and 7
5 treatments with ADVOS on day 1, 2, 3, 5 and 7
course of total bilirubin in patients blood
measurement of concentration of total bilirubin in serum of patients in mg/dl
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
course of uremia toxins in patients blood
measurement of blood urea nitrogen in serum of patients in mg/dl
Time frame: 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
Time frame: 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.)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
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
We will measure the Blood urea nitrogen (mg/dl) in a blood sample
Time frame: Within 6 hours before first treatment and within 2 hours after every treatment session
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Jun 2025, 24 months after the start.
Of 207 non-industry interventional studies with no phase under Liver Cirrhosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 73. This study's planned 24 months is below that.
Counting every sponsor, half of 216 studies reached it within 32 months; a quarter within 17 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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University Medical Center Mainz