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

Acute Kidney Injury Clinical Trial

— ESRD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03539861
• Other study ID #: HUM00125836
• Status: Terminated
• Phase: N/A
• Start date: September 24, 2019
• Est. completion date: August 4, 2021

Study information

• Verified date: November 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 4, 2021
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Disease Stage 5
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Myocardial Stunning
• Renal Insufficiency, Chronic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Renal Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Regional Wall Abnormalities Identified on Echocardiogram	Regional wall motion will be scored using a standard wall motion scoring scheme. (1= normal; 2=hypokinetic; 3= akinetic; 4=dyskinetic). Scores will be tabulated for each of 16 predefined segments and a global wall motion score calculated as the sum of individual scores divided by the number visualized segments.	Baseline, 5 hour, 24 hours
Secondary	Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa)	Number of participants who experienced a clinically significant change in systemic ionized calcium compared to reference range: 1.12 to 1.30.	Hour 1, hour 2, hour 3, hour 4, hour 5
Secondary	Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin	Number of participants who experienced a clinically significant change in hemoglobin who experience a change of more than 10% of baseline	Baseline, Hour 5, 24 hours