Acute Kidney Injury, Chronic Kidney Disease Stage 5, End Stage Renal Disease
Conditions
Keywords
End Stage Renal Disease, Hemodialysis, Chronic Kidney Disease Stage 5
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.
Interventions
DEVICEHemodialysis
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.
Sponsors
Renal Research Institute
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Regional Wall Abnormalities Identified on Echocardiogram | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa) | Hour 1, hour 2, hour 3, hour 4, hour 5 | 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 | Baseline, Hour 5, 24 hours | Number of participants who experienced a clinically significant change in hemoglobin who experience a change of more than 10% of baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Hemodialysis |
|---|---|
| Age, Customized 25-30 | 1 Participants |
| Age, Customized 62-68 | 1 Participants |
| Race/Ethnicity, Customized Black or African-American | 1 Participants |
| Race/Ethnicity, Customized White | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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.
Time frame: Baseline, 5 hour, 24 hours
Population: Regional wall motion was not able to be evaluated for one participant because of arrhythmia. Because sharing data about the other individual could violate privacy concerns, it is not analyzed or displayed.
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
Time frame: Baseline, Hour 5, 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hemodialysis | Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin | 0 Participants |
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.
Time frame: Hour 1, hour 2, hour 3, hour 4, hour 5
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hemodialysis | Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa) | 0 Participants |