Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 39 of 111 for:    CALCIUM CATION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539861
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Renal Research Institute
Information provided by (Responsible Party):
Lenar Yessayan, University of Michigan

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.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Acute Kidney Injury Chronic Kidney Disease Stage 5 Device: Hemodialysis Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.
Other Names:
  • Selective cytopheretic device
  • SCD
  • SCD filter anticoagulated with regional citrate




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Number of participants with an adverse event based on the Clinical laboratory measurement: Hemoglobin [ Time Frame: Baseline, Hour 5, 24 hours ]
    Descriptive analysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Lenar Yessayan 734-763-9041 lenar@umich.edu

Locations
Layout table for location information
United States, Michigan
The University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Amie Anderson         
Sponsors and Collaborators
University of Michigan
Renal Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Lenar Yessayan The University of Michigan Department of Internal Medicine

Layout table for additonal information
Responsible Party: Lenar Yessayan, Associate Professor of Internal Medicine, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT03539861    
Other Study ID Numbers: HUM00125836
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

Layout table for additional information
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
Keywords provided by Lenar Yessayan, University of Michigan:
End Stage Renal Disease
Hemodialysis
Chronic Kidney Disease Stage 5
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Kidney Failure, Chronic
Myocardial Stunning
Urologic Diseases
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms