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| ID | Type | Description | Link |
|---|---|---|---|
| 17193 | Other Identifier | Research Ethics Board |
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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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Peritoneal dialysis (PD) is the method of renal replacement therapy used by close to 200,000 end stage renal disease patients worldwide to help replace the functions that are no longer performed by their kidneys. An important advantage of PD is it offers an alternative to hemodialysis that can be safely performed by patients in their own homes. In PD, the peritoneal membrane that lines the abdomen acts as a dialyzer that allows the transfer of solutes and water between the membrane capillaries and a dialysis solution that is infused into the peritoneal cavity. PD dialysis solutions typically require high concentrations of glucose to adequately perform these functions. Over time the continued exposure of the peritoneal membrane to high concentrations of glucose can permanently damage the membrane. Icodextrin is a polyglucose molecule that has been developed for use in PD solutions that does not harm the peritoneal membrane. However, its use can lead to inadequate fluid removal. Recent research has focused on finding a PD solution, or combination of solutions, that will maximize the removal of toxic substances and metabolites while maintaining regulation of fluid and electrolyte balance in the body. A bimodal solution that combines glucose and icodextrin has been shown in observational studies to be effective and safe. The investigators propose a randomized, controlled, blinded study that will determine the effectiveness and safety of this bimodal fluid in a Canadian PD population. The investigators hypothesize that the use of the bimodal solution during the long (day) dwell will lead to an improvement in 24 hour ultrafiltration efficiency as compared to usual care using icodextrin for the long dwell.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bimodal solution | Experimental | 200 mls of 30% glucose in sterile water is added by the patient to the usual icodextrin day dwell, to create the bimodal solution intraperitoneally |
|
| icodextrin | Active Comparator | 200 mls of icodextrin is added by the patient to the usual icodextrin day dwell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimodal solution | Drug | 200 mL of 30% glucose infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler |
| Measure | Description | Time Frame |
|---|---|---|
| net ultrafiltration efficiency in mL/g | Ultrafiltration Efficiency (UFE): UFE is defined as the amount of 24 hour net Ultrafiltration (UF) obtained for every gram of carbohydrate absorbed from the dialysis solution.
| Calculated at baseline and at the end of the 6 week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour absolute total carbohydrate absorption | This will include both glucose and icodextrin absorption. | Calculated at baseline and at the end of the 6 week intervention period |
| 24-hour urine volume |
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Inclusion Criteria:
Be able to provide informed consent
Age greater than 18 years
Be stable Automated Peritoneal Dialysis (APD) patients for at least 6 weeks
Be APD patients who;
Have residual urine volume <800 ml/24 hours
Long dwell must be or patient must tolerate at least an 8-10 hr long dwell.
Exclusion Criteria:
Supplementary Exclusion Criteria (post Run-in phase):
1) Unsuccessfully completed 1 week run-in phase. Defined as:
i) Blood pressure drop below 90/50 on more than three occasions during a seven day period that cannot be corrected by reducing anti-hypertensives or other simple measures ii) Intolerable feeling of fullness with the bimodal solution iii) Allergic reaction (although all patients have already been exposed to icodextrin)
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| Name | Affiliation | Role |
|---|---|---|
| Arsh K Jain, MD | London Health Sciences Centre, Dept of Medicine, Victoria Campus, London Ontario | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre, South Street Hospital, Peritoneal Dialysis Unit | London | Ontario | N6A 5W9 | Canada |
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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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| ID | Term |
|---|---|
| D000077607 | Icodextrin |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| icodextrin | Drug | 200 mL of icodextrin infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler |
|
| Calculated at baseline and at the end of the 6 week intervention period |
| 24-hour net sodium removal (in both peritoneal effluent and urine) | Calculated at baseline and at the end of the 6 week intervention period |
| Volume measures as calculated by bioimpedance analysis | Calculated at baseline and at the end of the 6 week intervention period |
| Weight | Used as an indicator of fluid retention | Calculated at baseline and at the end of the 6 week intervention period |
| Mean and pulse arterial pressure | Calculated at baseline and at the end of the 6 week intervention period |
| Number of anti-hypertensive agents | Calculated at baseline and at the end of the 6 week intervention period |
| Renal (urine) solute clearance (Sodium, Urea, Creatinine) | Calculated at baseline and at the end of the 6 week intervention period |
| Peritoneal effluent solute clearance (Sodium, Urea, Creatinine) | Calculated at baseline and at the end of the 6 week intervention period |
| 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 |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |