| Trial ID: | L0921 |
| Source ID: | NCT01242904
|
| Associated Drug: |
Bimodal Solution
|
| Title: |
Use of a Bimodal Solution for Peritoneal Dialysis
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: bimodal solution|DRUG: icodextrin
|
| Outcome Measures: |
Primary: 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. 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), Calculated at baseline and at the end of the 6 week intervention period | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Collaborators: Baxter Healthcare Corporation
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| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-09-30
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| Completion Date: |
2015-02-28
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| Results First Posted: |
|
| Last Update Posted: |
2017-08-28
|
| Locations: |
London Health Sciences Centre, South Street Hospital, Peritoneal Dialysis Unit, London, Ontario, N6A 5W9, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT01242904
|
