Renal Failure Clinical Trial
— CYTOHEPOfficial title:
Cytokine Adsorption in Patients With Acute-on-chronic Liver Failure (CYTOHEP) - a Single Center, Open-label, Randomized, Controlled Intervention Trial
The CYTOHEP study is a prospective, randomized, single center, open-label, controlled intervention trial to assess the benefit of extracorporeal hemoadsorption using the CytoSorb device in patients with acute-on-chronic liver failure. The primary goal for this trial is to assess whether the CytoSorb device used in addition to continuous renal replacement therapy (CRRT) will be able to significantly reduce bilirubin in the patient blood as compared to the control group treated with CRRT alone (i.e., without extracorporeal hemoadsorption). The rationale for this study is based on considerations about the role of systemic inflammation in acute decompensation of liver cirrhosis and ACLF, in-vitro data of the effectiveness CytoSorb for the removal of molecules with a pathophysiological role in acute-on-chronic liver failure, and recent reports on the successful use of extracorporeal hemoadsorption in combination with CRRT in critically ill patients with acute liver dysfunction.
Status | Recruiting |
Enrollment | 51 |
Est. completion date | January 30, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Inclusion Criteria: - adult patients (= 18 years) admitted to the University Medical Center Freiburg, Germany - acute-on-chronic liver failure (ACLF) WITH 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 serum bilirubin = 5 mg/dl 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Clinic Freiburg | Freiburg |
Lead Sponsor | Collaborator |
---|---|
Dr. Alexander Supady |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum bilirubin | Serum bilirubin after 72 hours | 72 hours | |
Secondary | Survival time | Survival time from baseline | 30 days | |
Secondary | Interleukin-6 | Interleukin-6 after 72 hours | 72 hours | |
Secondary | Liver function parameters | Quick/INR, AST, ALT, AP, g-GT | 72 hours | |
Secondary | Blood lactate | Lactate concentration after 72 hours | 72 hours | |
Secondary | CLIF-SOFA-score | CLIF-SOFA-score | 72 hours | |
Secondary | MELD score | MELD score | 72 hours | |
Secondary | SOFA score | SOFA score | 72 hours | |
Secondary | SAPS II | SAPS II | 72 hours | |
Secondary | FIPS score | FIPS score | 72 hours | |
Secondary | Ventilator free days | 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 | 30 days | |
Secondary | vasopressor dosage | dosage of epinephrine, norepinephrine, dobutamine, argipressin and terlipressin | 72 hours | |
Secondary | Vasopressor free days | 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 | 30 days | |
Secondary | Dialysis free days | 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 | 30 days | |
Secondary | Inflammatory biomarkers | 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) | 72 hours |
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