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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
5 treatments with hemodialysis on day 1, 2, 3, 5 and 7
5 treatments with ADVOS on day 1, 2, 3, 5 and 7
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik
Mainz, Rhineland-Palatinate, Germany
RECRUITINGcourse 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
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