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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to investigate if the use of Extraneal (which is a mixture of high weight glucose polymers), instead of glucose-based solutions such as Dianeal is going to lower the HOMA index in non-diabetic CAPD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dianeal only | Active Comparator | Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange |
|
| Dianeal; Extraneal long-dwell exchange | Active Comparator | Patients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Procedure | Samples taken monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| HOMA index | Measure the changes in the levels of the HOMA index when Extraneal (7.5%) is being administered in the long-dwell exchange and compare these levels to the HOMA index resulting when using Dianeal 2.5% in the long-dwell exchange in non-diabetic CAPD patients. This outcome will be evaluated by measurements taken monthly over a period of 4 months. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | 12 months | |
| Ultrafiltration of long-dwell exchange | 12 months | |
| Blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauricio R Sanabria, M.D. | Baxter, RTS Colombia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bogotá | Colombia |
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| Measure of peritoneal ultrafiltrates | Procedure | Measured by the investigators intermittently and by the patients themselves on a monthly basis |
|
| 12 months |
| Quality of life | 12 months |
| Hospitalization rate | 12 months |
| Time during hospitalization | 12 months |
| Incidence of Adverse Events | 12 months |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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