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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2021-08-04

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Hemodialysis

Intervention Type DEVICE

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.

Interventions

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Hemodialysis

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.

Intervention Type DEVICE

Other Intervention Names

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Selective cytopheretic device SCD SCD filter anticoagulated with regional citrate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No