New device hopes to help kidneys in liver patients
NCT ID NCT04898010
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a device called the Selective Cytopheretic Device (SCD) in ICU patients with acute kidney injury and hepatorenal syndrome, a serious complication of liver disease. The device filters white blood cells from the blood for 7 days to see if it improves kidney function and blood circulation. The study involves 10 participants who are not on a liver transplant list and have worsening kidney failure. The main goals are to check safety and whether the device helps patients become dialysis-free.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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Other studies related to the condition(s) this trial covers.
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