Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ESRD)
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|ClinicalTrials.gov Identifier: NCT03539861|
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : September 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease Acute Kidney Injury Chronic Kidney Disease Stage 5||Device: Hemodialysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ERSD)|
|Actual Study Start Date :||September 24, 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
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.
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.
- Change in regional wall abnormalities identified on echocardiogram [ Time Frame: Baseline, 5 hour, 24 hours ]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.
- Number of participants with an adverse event based on the Clinical laboratory measurement: ionized calcium (iCa) [ Time Frame: Hour 1, hour 2, hour 3, hour 4, hour 5 ]Descriptive analysis
- Number of participants with an adverse event based on the Clinical laboratory measurement: Hemoglobin [ Time Frame: Baseline, Hour 5, 24 hours ]Descriptive analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539861
|Contact: Lenar Yessayanemail@example.com|
|United States, Michigan|
|The University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Amie Anderson|
|Principal Investigator:||Lenar Yessayan||The University of Michigan Department of Internal Medicine|