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Selective Cytopheretic Device

SCD for Acute Kidney Injury and Hepatorenal Syndrome

N/A
Recruiting
Research Sponsored by Lenar Yessayan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Worsening renal failure most likely due to Hepatorenal Syndrome Type I with low glomerular filtration rate (GFR)
No sustained improvement in renal function or intolerant to treatment with octreotide and /or midodrine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (prior to dialysis), days 1-5 post scd, days 30 and 90 (among survivors and those free from dialysis) (+/- 7 days)
Awards & highlights

Study Summary

This trial is testing a device that may help improve white blood cell counts and circulation in people with liver and kidney failure.

Who is the study for?
This trial is for adults with cirrhosis and ascites who have Hepatorenal Syndrome Type I without improvement after specific treatments, can tolerate certain therapies, and are in intensive care. Excluded are those with organ transplants, severe heart disease, HIV/AIDS, high risk of dying within 90 days (MELD score >40), or on other clinical trials.Check my eligibility
What is being tested?
The study tests the Selective Cytopheretic Device (SCD) over a week to see its effects on white blood cells in the bloodstream, circulation, and kidney function in patients with hepatorenal syndrome.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to device use such as blood clotting issues or infections due to prolonged CRRT therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My worsening kidney failure is likely due to Type I Hepatorenal Syndrome with a low GFR.
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My kidney function hasn't improved with octreotide/midodrine, or I can't tolerate them.
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I can undergo a specific blood thinning treatment and kidney support therapy for more than a day.
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I am not pregnant or breastfeeding, confirmed by a test.
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I am currently being treated in an intensive care unit.
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I have cirrhosis with fluid buildup in my abdomen.
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I don't have shock, ongoing infections, fluid loss, or take harmful meds for kidneys, and I don't have liver cancer.
Select...
My kidney function did not improve after treatment to remove excess fluid.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number if events with evidence of leakage (i.e., cracking/breakage of a port, connector, SCD casing cartridge or tubing).
Number of deaths related to selective cytopheretic device
Number of events of significant clotting within the device as assessed by visual inspection
+2 more
Secondary outcome measures
Change in coagulation parameters
Change in liver function
Change in model for end-stage liver disease (MELD) score
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Selective Cytopheretic DeviceExperimental Treatment1 Intervention
Subjects will be placed on Selective Cytopheretic Device (SCD) for planned daily 24 hour therapy for up to 7 consecutive days.

Find a Location

Who is running the clinical trial?

Lenar YessayanLead Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Hepatorenal Syndrome Research Study Groups: Selective Cytopheretic Device
~1 spots leftby Oct 2024
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