This research study is being done to learn what effect 7 days of treatment with the Selective Cytopheretic Device (SCD) will have on these white blood cells in the bloodstream of patients with hepatorenal syndrome and to learn whether it has any effect on the blood circulation and kidney function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The Selective Cytopheretic Device (SCD) treatment will be delivered using a two-cartridge system using a type of dialysis equipment commonly used for conventional hemodialysis therapy. The SCD cartridge will be added immediately post-hemofilter to the circuit of a standard hemodialysis system, and treatment will be delivered for 24 hours. Blood exchange will occur using a dialysis catheter.
University of Michigan
Ann Arbor, Michigan, United States
Number of serious adverse events related to selective cytopheretic device (SCD)
Time frame: Up to 90 days
Number of deaths related to selective cytopheretic device
Time frame: Up to 90 days
Number of events of significant clotting within the device as assessed by visual inspection
Source documentation will record either present, absent, or not-assessed
Time frame: Up to 7 days
Number of unforeseen malfunction(s) that results in the need for discontinuation
Time frame: Up to 7 days
Number if events with evidence of leakage (i.e., cracking/breakage of a port, connector, SCD casing cartridge or tubing).
Time frame: Up to 7 days
Dialysis independence
Dialysis independence at days 1-5 post SCD, and at days 30 and 90 (+/- 7 days). Dialysis independence will be assessed using the medical record.
Time frame: Up to 90 (+/- 7 days)
Change in renal function
As measured by serum creatinine from baseline (prior to dialysis initiation) at days 1-5 post SCD and at days 30 and 90 (among survivors and those free from dialysis).
Time frame: Baseline (prior to dialysis), days 1-5 post SCD, days 30 and 90 (among survivors and those free from dialysis) (+/- 7 days)
Change in liver function
Measured by blood tests of liver function parameters such as AST, ALT, alkaline phosphatase
Time frame: Baseline, at days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors)
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Change in liver function
Measured by blood test of bilirubin
Time frame: Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).
Change in coagulation parameters
Coagulation parameters include Prothrombin Time (PT), Activated Partial Thromboplastin Time (PTT), and International Normalized Ratio (INR) all reported in seconds
Time frame: Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).
Change in model for end-stage liver disease (MELD) score
MELD score is a number that ranges from 6 (least sick) to 40 (most sick) based on blood tests which ranks the degree of sickness from liver disease.
Time frame: Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).