Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | April 2019 |
| End Date: | October 2021 |
| Contact: | Amie Anderson |
| Email: | acander@umich.edu |
| Phone: | 734-998-9966 |
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.
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.
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
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