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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The ASIST study is a medical device study testing the safety and efficacy of a new hemodialysis machine software in chronic haemodialysis patients. The software's intention is to reduce hemodialysis related symptoms such as unwell being, blood pressure changes by adapting the dialysis fluid ion concentration to the patients plasma ion concentration by conductivity measurement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASIST A | Experimental | Artis Haemodialysis Machine w/ ASIST Software - Isonatremic |
|
| ASIST B | Experimental | Artis Haemodialysis Machine w/ ASIST Software - Isotonic |
|
| Conventional HD | Active Comparator | Artis Haemodialysis Machine w/o ASIST Software |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artis Haemodialysis Machine w/ ASIST Software - Isonatremic | Device |
| ||
| Artis Haemodialysis Machine w/ ASIST Software - Isotonic |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Blood Pressure | Up to 9 weeks | |
| Evaluation of Heart Rate | Up to 9 weeks | |
| Occurrence of Hypotensive Episodes | Up to 9 weeks | |
| Change in Plasma Sodium | Up to 9 weeks | |
| Change in Plasma Tonicity | Up to 9 weeks | |
| Change in MCV (Erythrocyte Mean Corpuscular Volume) | Up to 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skane University Hospital | Malmö | Skåne County | 205 02 | Sweden |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Device |
|
| Artis Haemodialysis Machine w/o ASIST Software | Device |
|
| 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 |