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| Name | Class |
|---|---|
| Tufts Medical Center | OTHER |
| Dialysis Clinic, Inc. | INDUSTRY |
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The overall goal is to evaluate the predictive accuracy of a measure of autoregulatory adequacy derived from CVInsight and compare it with other measures in recognizing hypotensive events during hemodialysis..
Specific Aims are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dialysis patients with greater than 20% IDH | Study Population: The sample will be enriched for subjects prone to IDH, defined as patients who experience IDH for greater than 20% of HD treatments in the past 2 months. The study population will consist of 48 patients total, 75% of patients (n=36) prone to IDH and 25% of patients with less than 10% of IDH during the last two months (n=12). | ||
| Patients with less than 10% IDH | Study Population: The sample will be enriched for subjects prone to IDH, defined as patients who experience IDH for greater than 20% of HD treatments in the past 2 months. The study population will consist of 48 patients total, 75% of patients (n=36) prone to IDH and 25% of patients with less than 10% of IDH during the last two months (n=12). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of intradialytic hypotensive (IDH) episodes that can be detected by the new rule set for CVInsight. | IDH defined by at least one of the following: 1) Symptoms of hypotension: dizziness, cramping, altered consciousness, nausea +/- vomiting (new since beginning of session), chest pain, shortness of breath, seizure, diaphoretic. 2) Intervention administered due to IDH; relevant interventions:a) a reduction in ultrafiltration (UF) goal programmed at start of treatment (tx); b) admin. of IV fluid, e.g. saline, mannitol or hypertonic saline; c) stopping tx early due to IDH symptoms or event. 3) A significant drop in blood pressure, regardless of symptoms, defined as:
| 3-4 hours, for two hemodialysis session, or 6-8 hours total |
| Measure | Description | Time Frame |
|---|---|---|
| The comparative, predictive accuracy of CVInsight® and CRIT-LINE III with regard to intradialytic hypotensive events. | CVInsight® and CRIT-LINE III will have different predictive accuracies in recognizing IDH episodes. Receiver Operator Characteristics analysis of CVInsight and CRIT-LINE CVInsight: Event level thresholds will be triggered based upon new proprietary rule set. CRIT-LINE: Change in hematocrit of 8% per hour or 15% over the treatment. |
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Inclusion Criteria:
Eligibility shall consist of the following:
Exclusion criteria for both groups:
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Study Population:
The sample will be enriched for subjects prone to IDH, defined as patients who experience IDH for greater than 20% of HD treatments in the past 2 months. The study population will consist of 48 patients total, 75% of patients (n=36) prone to IDH and 25% of patients with less than 10% of IDH during the last two months (n=12).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
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| 3-4 hours, for two hemodialysis session, or 6-8 hours total |
| Amount of post-dialytic vascular refill as separately indicated by both CVInsight® and CRIT-LINE III. | Post-dialytic vascular refill will indirectly reflect hydration status and accuracy of dry weight estimation. Vascular refill -Ten minutes prior to the end of treatment, with UFR at zero, and BFR at same rate as during treatment, measurements will continue to be taken via the CVInsight® and CRIT-LINE devices to assess vascular refill. CVInsight: Increase in pulse amplitude. CRIT-LINE: Increase of 0.5% increase in hematocrit (HCT) over 10 minutes. | At the end of each dialysis session after the ultrafiltration rate (UFR) has turned off. |
| The occurrence and frequency of arrhythmias as indicated on the Zio ECG Patch and the levels of cardiac Troponin T, taken prior to each HD treatment. which are indicative HD-induced myocardial injury.. | Arrhythmias frequency overall, on dialysis days, during long and short interdialytic periods, nocturnal, diurnal. Troponin T levels will correlate with the incidence rates of arrhythmias. Troponin T as measured by ng/mL, reference value at <0.011 | 24 hours before first session of monitored dialysis to at least 24 hours after the second session on monitored dialysis sessions. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |