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COVID- pandemic, nursing shortages. enrolled two patients then not enough nurses in dialysis unit to be able to attend to patients
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| Name | Class |
|---|---|
| Renal Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialysis | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemodialysis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lenar Yessayan | The University of Michigan Department of Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Baseline, 5 hour, 24 hours |
|
8 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lenar Yessayan | University of Michigan | 734-763-9041 | lenar@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2022 | Nov 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D058186 | Acute Kidney Injury |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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|
|
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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | Baseline, Hour 5, 24 hours |
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|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |