Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients

Not Applicable

Terminated

Conditions: End Stage Renal Disease
Acute Kidney Injury
Chronic Kidney Disease Stage 5

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Hemodialysis	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.

Primary Outcome Measures

Name	Time	Method
Change in Regional Wall Abnormalities Identified on Echocardiogram	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa)	Hour 1, hour 2, hour 3, hour 4, hour 5	Number of participants who experienced a clinically significant change in systemic ionized calcium compared to reference range: 1.12 to 1.30.
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin	Baseline, Hour 5, 24 hours	Number of participants who experienced a clinically significant change in hemoglobin who experience a change of more than 10% of baseline

Locations (1): The University of Michigan
🇺🇸
Ann Arbor, Michigan, United States

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