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

University of Michigan

Status: Terminated

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

Treatments: Device: Hemodialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03539861

HUM00125836

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Hemodialysis

Other group

Description:

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.

Treatment:

Device: Hemodialysis