Intermittent ADVOS vs. Hemodialysis in Non-intensive Care Patients With Liver Dysfunction
- Conditions
- Kidney Failure, AcuteKidney ReplacementMulti Organ FailureLiver Cirrhosis
- Interventions
- Device: ADVOSDevice: Hemodialysis
- Registration Number
- NCT06129617
- Lead Sponsor
- University Medical Center Mainz
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 14
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ADVOS ADVOS Patients receiving ADVOS therapy with ADVOS multi Hemodialysis Hemodialysis Patients receiving hemodialysis therapy mit Fresenius 5008
- Primary Outcome Measures
Name Time Method course of total bilirubin in patients blood 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
- Secondary Outcome Measures
Name Time Method number of days in hospital during the intervention admission in our department till discharge from our deparment we will measure the number of days in the hospital during the intervention from admission to our department until discharge from our department
evaluation of safety of ADVOS versus hemodialysis during the five interventions Rate of complications during procedure (for example hypotension, electrolyte disorders etc.)
course of albumin Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the albumin (in g/l) in a blood sample
course of base excess Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the base excess (mmol/l) in a blood sample with blood gas system (ABL800 FLEX Plus)
course of standard bicarbonat concentration Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the standard bicarbonat concentration (mmol/l) in a blood sample with blood gas system (ABL800 FLEX Plus)
course of potassium Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the potassium (mmol/l) in a blood sample with blood gas system (ABL800 FLEX Plus)
course of uremia toxins in patients blood Within 6 hours before first treatment and within 2 hours after every treatment session measurement of blood urea nitrogen in serum of patients in mg/dl
course of bile acids Within 6 hours before first treatment and within 2 hours after every treatment session measurement of bile acids in serum of patients in mg/dl
Quality of life raised in a standardized questionnaire baseline before intervention and on days 28, 90, 180 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
course of INR Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the INR in a blood sample
course of MELD Within 6 hours before first treatment and within 2 hours after 5 treatments MELD = Model for End-stage Liver Disease (6-40, Higher numbers indicate increased mortality)
course of pO2 Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the pO2 (in mmHg) in a blood sample with blood gas system (ABL800 FLEX Plus)
course of pCO2 Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the pCO2 (in mmHg) in a blood sample with blood gas system (ABL800 FLEX Plus)
course of ionised calcium Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the ionised calcium (mmol/l) in a blood sample with blood gas system (ABL800 FLEX Plus)
mortality 28, 90 and 180 days. course of pH Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the pH in a blood sample with blood gas system (ABL800 FLEX Plus)
course of bilirubin Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the bilirubin (in mg/dl) in a blood sample
course of kidney function Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the kreatinine (in mg/dl) in a blood sample
course of CLIF-C ACLF score Within 6 hours before first treatment and within 2 hours after 5 treatments CLIF-C ACLF Score = Chronich Liver failure Consortium acute on chronic liver failure score (6-15, higher numbers indicate increased mortality)
course of sodium Within 6 hours before first treatment and within 2 hours after every treatment session we will measure the sodium (mmol/l) in a blood sample with blood gas system (ABL800 FLEX Plus)
elimination of blood urea nitrogen Within 6 hours before first treatment and within 2 hours after every treatment session We will measure the Blood urea nitrogen (mg/dl) in a blood sample
course of hepatic encephalopathy Within 6 hours before first treatment and within 2 hours after every treatment session 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)
Trial Locations
- Locations (1)
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik
🇩🇪Mainz, Rheinland-Pfalz, Germany