K74.72
Conditions
Interventions
Group 1: Continuous renal replacement therapy with cytokine adsorption for 72 hours
Group 2: Continuous renal replacement therapy without cytokine adsorption
Group 3: No continuous renal replacement t
Sponsors
Universitätsklinikum Freiburg Department Innere Medizin Klinik für Innere Medizin III
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Adult patients (= 18 years) admitted to the University Medical Center Freiburg, Germany - acute-on-chronic liver failure (ACLF) WITH a) acute kidney injury according to Kidney Disease: Improving Global Outcome (KDIGO) criteria stage 3 (= 3-fold increase of serum creatinine OR increase of serum creatinine to = 4 mg/dl OR urine output = 0.3 ml/kg/h for = 24 hours OR anuria for = 12 hours) AND b) serum bilirubin = 5 mg/dl
Exclusion criteria
Exclusion criteria: - known patient will against participation in the study or against the measures applied in the study - a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours - no complete remission of malignancy including hepatocellular carcinoma within the past 12 months - patients on the waiting list for liver transplant or the potential option for being listed for liver transplant within the next 6 months - liver cirrhosis in patients after liver transplantation - ongoing intermittent or continuous renal replacement therapy before study inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum bilirubin reduction after 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| - Survival time from baseline (up to day 30, 60 and 90) - Interleukin-6 after 72 hours - Improvement of a) liver function parameters (72 hours): Quick/INR, AST, ALT, AP, g-GT, Blood lactate (72 hours) b) clinical scores: CLIF-SOFA-score, MELD score, SOFA score, SAPS II and FIPS score (72 hours) - Ventilator free days (VeFD) in the first 30 days after randomization, where each day on invasive mechanical ventilation (IMV), non-invasive ventilation (NIV), or ECMO is defined as ventilator day. VeFD=0, if the patient dies in the first 30 days after randomization - vasopressor dosage (epinephrine, norepinephrine, dobutamine, argipressin and terlipressin) at 72 hours - Vasopressor free days (VaFD) in the first 30 days after randomization, where each day with any dose of epinephrine, norepinephrine, dobutamine, argipressin or terlipressin is defined as vasopressor day. VaFD=0, if the patient dies in the first 30 days after randomization - Dialysis free days (DFD) in the first 30 days after randomization, where each day on renal replacement therapy (RRT) is defined as dialysis day. DFD=0, if the patient dies in the first 30 days after randomization - A biomarker panel of pro- and anti-inflammatory cytokines (blood samples will be frozen and stored for later analyses, panel will be determined at the time of analysis) | — |
Countries
Germany
Contacts
Public ContactAlexander Supady
Universitätsklinikum Freiburg Department Innere Medizin Klinik für Innere Medizin III
Outcome results
None listed