Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ESRD)
Primary Purpose
End Stage Renal Disease, Acute Kidney Injury, Chronic Kidney Disease Stage 5
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hemodialysis
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring End Stage Renal Disease, Hemodialysis, Chronic Kidney Disease Stage 5
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
Sites / Locations
- The University of Michigan
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hemodialysis
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT03539861
First Posted
May 16, 2018
Last Updated
December 18, 2022
Sponsor
University of Michigan
Collaborators
Renal Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03539861
Brief Title
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
Acronym
ESRD
Official Title
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ERSD)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID- pandemic, nursing shortages. enrolled two patients then not enough nurses in dialysis unit to be able to attend to patients
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
August 4, 2021 (Actual)
Study Completion Date
August 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Renal Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Acute Kidney Injury, Chronic Kidney Disease Stage 5
Keywords
End Stage Renal Disease, Hemodialysis, Chronic Kidney Disease Stage 5
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemodialysis
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Hemodialysis
Other Intervention Name(s)
Selective cytopheretic device, SCD, SCD filter anticoagulated with regional citrate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Regional Wall Abnormalities Identified on Echocardiogram
Description
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.
Time Frame
Baseline, 5 hour, 24 hours
Secondary Outcome Measure Information:
Title
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa)
Description
Number of participants who experienced a clinically significant change in systemic ionized calcium compared to reference range: 1.12 to 1.30.
Time Frame
Hour 1, hour 2, hour 3, hour 4, hour 5
Title
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin
Description
Number of participants who experienced a clinically significant change in hemoglobin who experience a change of more than 10% of baseline
Time Frame
Baseline, Hour 5, 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lenar Yessayan
Organizational Affiliation
The University of Michigan Department of Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
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