Clinical trial NCT03539861: Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
Official title: Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ERSD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Disease
Acute Kidney Injury
Chronic Kidney Disease Stage 5
Keywords: End Stage Renal Disease
Hemodialysis
Chronic Kidney Disease Stage 5
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Renal Research Institute
First posted: 2018-05-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Regional Wall Abnormalities Identified on Echocardiogram
timeFrame: Baseline, 5 hour, 24 hours
Secondary outcomes:
measure: Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa)
timeFrame: Hour 1, hour 2, hour 3, hour 4, hour 5
measure: Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin
timeFrame: Baseline, Hour 5, 24 hours
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: The University of Michigan Department of Internal Medicine
name: Lenar Yessayan
role: PRINCIPAL_INVESTIGATOR
References: