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

Stopped early · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03539861

Run by

University of Michigan

People needed

2

Starts

2019-09-24

Expected to finish

2021-08-04

Last updated by the study team

2023-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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