Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ESRD)
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ERSD)
Hemodialysis is a therapy that filters waste, removes extra fluid and balances electrolytes. In hemodialysis, blood is removed from the body and filtered through a man-made membrane called a dialyzer, and then the filtered blood is returned to the body. Hemodialysis is associated with injury to the heart muscle called myocardial stunning. This may occur for many reasons, including removal of fluid during dialysis or low blood pressure. Initial ischemia and subsequent white blood cell infiltration into the injured myocardium play a critical role in the degree of myocardial ischemia reperfusion injury.
In this study an additional man made membrane (selective cytopheretic device) and tubing will be added to the dialysis circuit. The device shifts the circulating white blood cells pool to a less inflammatory phenotype. Researchers believe the selective cytopheretic device will alter the phenotype of circulating white blood cells which play a role in myocardial stunning.
The purpose of this study is to evaluate whether the selective cytopheretic device will reduce myocardial stunning events in hemodialysis patients. It will also report the rate of adverse events.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- The University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- End-stage renal disease (Chronic Kidney Disease Stage 5)
- Receiving hemodialysis 3 times/week for over 3 months
- Baseline blood pressure before hemodialysis has been ≥ 100/50 over preceding 4 weeks
- Recurrent weight gain between hemodialysis sessions
Exclusion Criteria:
- Any active inflammatory condition (e.g., gout, systemic lupus erythematosus flare, hepatitis B or C infection, allograft rejection, subcutaneous injection of illicit drugs, "skin popping")
- Treatment with immunosuppressive therapy within 30 days of study
- Blood levels within a specified range
- Woman who is pregnant, breast feeding a child, or is trying to become pregnant
- Heart weakness or failure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Hemodialysis
The treatment arm (all participants are in this arm) is done in two phases that are described below: Treatment 1 will be standard hemodialysis (no device). Treatment 2 will be hemodialysis with the study device. Of importance, this 5 hour session is planned to ensure adequate solute clearance but with only 4 hour high ultrafiltration to achieve the patients dry weight. |
Each patient will receive two hemodialysis treatments while on this study.
The first hemodialysis treatment will be standard of care hemodialysis.
The second treatment will be the experimental hemodialysis treatment using the Selective cytopheretic device.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Regional Wall Abnormalities Identified on Echocardiogram
Time Frame: Baseline, 5 hour, 24 hours
|
Regional wall motion will be scored using a standard wall motion scoring scheme.
(1= normal; 2=hypokinetic; 3= akinetic; 4=dyskinetic).
Scores will be tabulated for each of 16 predefined segments and a global wall motion score calculated as the sum of individual scores divided by the number visualized segments.
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Baseline, 5 hour, 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa)
Time Frame: Hour 1, hour 2, hour 3, hour 4, hour 5
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Number of participants who experienced a clinically significant change in systemic ionized calcium compared to reference range: 1.12 to 1.30.
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Hour 1, hour 2, hour 3, hour 4, hour 5
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Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin
Time Frame: Baseline, Hour 5, 24 hours
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Number of participants who experienced a clinically significant change in hemoglobin who experience a change of more than 10% of baseline
|
Baseline, Hour 5, 24 hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lenar Yessayan, The University of Michigan Department of Internal Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00125836
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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