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This is a research study to test the application of FDA-approved, non-invasive device (NICaS) that measure the performance of your heart during HD treatment.
The incidence of intradialytic hypotension (IDH) events, reported to occur in 15% to 50% of hemodialysis (HD) treatments, is still high despite major technical advances in HD technology. By definition, excessive reduction in intravascular volume by ultrafiltration and limited vascular refilling from tissues into the vascular space is the cause of IDH. Chronic HD patients exhibit a high prevalence of peripheral vascular and cardiac abnormalities. Specifically, hemodynamic instability during HD can occur due to insufficient reduction in venous unstressed volume, poor diastolic filling under reduced atrial pressures associated with diastolic dysfunction, altered cardiac contractility, and impaired vascular reactivity. An IDH event can lead to myocardial cerebral and other organ ischemia. Long- and short-term adverse outcomes have been associated with IDH, a common HD complication and significant cause of morbidity.
Recent pilot studies suggest that in IDH-prone subjects, measurements of hemodynamic variables during HD can be used to categorize the hemodynamic response into three subgroups: cardiac power index (CPI) reduction with stable total peripheral resistance (TPR), TPR reduction with stable CPI, and reduction in TPR and CPI groups. It is hypothesized that targeted intervention for each subgroup can reduce IDH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Group 1 | Experimental | pressure stockings worn during dialysis treatment |
|
| Phase 1 Group 2 | Experimental | Midodrine before dialysis treatment |
|
| Phase 1 Group 3 | Experimental | pressure stocking and Midodrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pressure stockings | Device | pressure stockings worn during dialysis throughout treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension | Post dialysis BP measured in mm/Hg | 6 weeks |
| Weight | Post dialysis weight measure in kg | 6 weeks |
| Cardiac Index | Cardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2 | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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There is no current plan to share IPD with other researchers
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 8, 2018 | |
| Reset | Dec 7, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 8, 2018 | Dec 7, 2018 |
| ID | Term |
|---|---|
| D053828 | Stockings, Compression |
| D008879 | Midodrine |
| ID | Term |
|---|---|
| D058128 | Compression Bandages |
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
| D004983 | Ethanolamines |
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| Midodrine | Drug | administered Midodrine before each dialysis treatment during treatment period based on PI's judgement. Including consideration of blood pressure. |
|
| pressure stockings and midodrine | Other | combination of Midodrine and pressure stocking before each dialysis treatment throughout treatment period |
|
| D000605 |
| Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |