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| Name | Class |
|---|---|
| Universidad de Córdoba | OTHER |
| Baxter Healthcare Corporation | INDUSTRY |
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This clinical study is designed to evaluate the theoretical prediction of a lower glucose absorption in optimized automated peritoneal dialysis regimes. Patients will receive both a standard 6 x 2L 1.36% glucose regime or an optimized 7 x 2 L 2.27% glucose + 5 x 2 L 0.1% glucose regime in a crossover fashion.
Automated peritoneal dialysis (APD) is a rapidly growing, home-based kidney replacement therapy promoting patient autonomy, and is associated with lower societal costs compared to hemodialysis. However, in light of the growing number of diabetic patients on PD, the unwanted glucose absorption during APD is problematic. Recent results (Öberg CM, Rippe B, 2017, see references), using a theoretical model of APD, indicate that large reductions in glucose absorption are possible by using specialized so-called optimized bi-modal treatment regimes having "UF cycles" using a higher glucose concentration (e.g. 2.27% glucose) and "Clearance cycles" using a low glucose concentration (e.g. 0.1% glucose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment | Active Comparator | APD-treatment with a net volume of 12 L 1.36 % anhydrous glucose peritoneal dialysis solution during 540 minutes. |
|
| Optimized treatment | Active Comparator | APD-treatment with a net volume of 14 L 2.27 % anhydrous glucose peritoneal dialysis solution during 280 minutes followed by a net volume of 10 L 0.1 % glucose dialysis fluid during 200 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated peritoneal dialysis (APD) | Procedure | Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose absorption | Amount of glucose absorbed across the peritoneal membrane during the treatment | Through study completion, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrafiltration | Amount of water transported from the circulation to the peritoneal cavity during the treatment | Through study completion, up to 1 year |
| Creatinine clearance | Amount of creatinine transported from the circulation to the peritoneal cavity during the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl M Öberg, M.D., Ph.D. | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Privado Centro Médico de Córdoba | Córdoba | 5016 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29270500 | Background | Oberg CM, Rippe B. Optimizing Automated Peritoneal Dialysis Using an Extended 3-Pore Model. Kidney Int Rep. 2017 Apr 27;2(5):943-951. doi: 10.1016/j.ekir.2017.04.010. eCollection 2017 Sep. | |
| 32528722 | Derived | Bergling K, de Arteaga J, Ledesma F, Oberg CM. Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): study protocol for a randomized controlled crossover trial. Pilot Feasibility Stud. 2020 Jun 10;6:81. doi: 10.1186/s40814-020-00620-2. eCollection 2020. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Through study completion, up to 1 year |
| Urea clearance | Amount of urea transported from the circulation to the peritoneal cavity during the treatment | Through study completion, up to 1 year |
| Sodium removal | Amount of sodium transported from the circulation to the peritoneal cavity during the treatment | Through study completion, up to 1 year |
| Incidence of complications | Complications that are or can be suspected to be related to the study intervention | Up to 14 days post-intervention |
| 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 |