The Selective Cytopheretic Device (SCD) for Acute Kidney Injury (AKI) and Hepatorenal Syndrome (HRS) Type I
Not Applicable
Recruiting
- Conditions
- Acute Kidney InjuryHepatorenal Syndrome
- Interventions
- Device: Selective Cytopheretic Device
- Registration Number
- NCT04898010
- Lead Sponsor
- Lenar Yessayan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Cirrhosis with ascites.
- Not currently listed for liver transplant.
- Worsening renal failure most likely due to Hepatorenal Syndrome Type I with low glomerular filtration rate (GFR).
- No sustained improvement in renal function after diuretic withdrawal and expansion of plasma volume with 1.5 liters of plasma expander.
- No sustained improvement in renal function or intolerant to treatment with octreotide and /or midodrine.
- Able to tolerate regional citrate anticoagulation and continuous renal replacement therapy (CRRT) for 24 hours or greater.
- Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
- Receiving medical care in an intensive care unit.
- Absence of shock, ongoing bacterial infection and fluid losses, and current treatment with nephrotoxic medications, hepatocellular carcinoma.
- Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
- Two (2) consecutive intra-circuit Ionized Calcium (iCa) levels <0.40 Millimoles per liter (mmol/L), at least 30 minutes apart.
Exclusion Criteria
- Evidence of chronic kidney disease Stage 4.
- Patients with Model for End-Stage Liver Disease (MELD) score > 40 (since these patients are unlikely to survive a 90-day follow-up period).
- Acute or chronic use of circulatory support device.
- Mechanical ventilation for greater than 7 consecutive days.
- AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine or tacrolimus nephrotoxicity. No evidence of intrinsic parenchymal renal disorder, ultrasonic evidence of obstructive uropathy or proteinuria greater than 500 mg/day.
- Presence of any organ transplant at any time.
- Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three-month period after study protocol therapy.
- Severe, uncontrolled cardiac disease.
- Chronic immunosuppression.
- Medical history of HIV or AIDS.
- Current Do Not Attempt Resuscitation (DNAR), Allow Natural Death (AND), or withdrawal of care status, or anticipated change in status within the next 7 days.
- Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
- Dry weight >150 kg.
- Platelet count <30,000/mm3.
- Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical studies where only measurements and/or samples are taken (i.e., no test device or test drug used) are allowed to participate
- Use of any other investigational drug or device within the previous 30 days
- Patient is a prisoner.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Selective Cytopheretic Device Selective Cytopheretic Device Subjects will be placed on Selective Cytopheretic Device (SCD) for planned daily 24 hour therapy for up to 7 consecutive days.
- Primary Outcome Measures
Name Time Method Number of serious adverse events related to selective cytopheretic device (SCD) Up to 90 days Number of deaths related to selective cytopheretic device Up to 90 days Number of unforeseen malfunction(s) that results in the need for discontinuation Up to 7 days Number if events with evidence of leakage (i.e., cracking/breakage of a port, connector, SCD casing cartridge or tubing). Up to 7 days Number of events of significant clotting within the device as assessed by visual inspection Up to 7 days Source documentation will record either present, absent, or not-assessed
- Secondary Outcome Measures
Name Time Method Change in renal function Baseline (prior to dialysis), days 1-5 post SCD, days 30 and 90 (among survivors and those free from dialysis) (+/- 7 days) 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).
Change in coagulation parameters 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). Coagulation parameters include Prothrombin Time (PT), Activated Partial Thromboplastin Time (PTT), and International Normalized Ratio (INR) all reported in seconds
Change in liver function 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). Measured by blood test of bilirubin
Dialysis independence Up to 90 (+/- 7 days) 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.
Change in model for end-stage liver disease (MELD) score 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). 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.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States