Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01242904 | Use of a Bimodal Solution for Peritoneal Dialysis | PHASE2 | COMPLETED | 36 | — | — | Sep 30, 2010 | Feb 28, 2015 | Aug 28, 2017 | 1 | Canada |
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. 1. 24-hour net ultrafiltration (in mL) is recorded automatically by the Automated Peritoneal Dialysis (APD) cycler. 2. Carbohydrate absorption is determined by calculating the difference (in grams) between the amount of glucose (measured by lab analysis) in the 24 hr peritoneal effluent, and the amount of glucose in the patient's dialysis prescription. 3. UFE will be calculated in mL/g (ie a divided by b)
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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 |
| 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 |
Inclusion Criteria: 1. Be able to provide informed consent 2. Age greater than 18 years 3. Be stable Automated Peritoneal Dialysis (APD) patients for at least 6 weeks 4. Be APD patients who; 1. Can be managed with an icodextrin long dwell AND 2. Will use 4.25% and/or a 2.5% solution for at l...