Status:
COMPLETED
Use of a Bimodal Solution for Peritoneal Dialysis
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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;
- Can be managed with an icodextrin long dwell AND
- Will use 4.25% and/or a 2.5% solution for at least one exchange overnight in at least 5 out of 7 days
- 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
- Scheduled Transplant in the next 1 year
- Life expectancy \< 3 mo (estimated by physician)
- Participating in other trial that could influence outcome of this trial
- Known icodextrin allergy
- Currently using non-Baxter PD solutions
- Systolic blood pressure \< 90 mm Hg on more than three occasions during a seven day period, despite discontinuation of non-essential anti-hypertensives
- Supplementary Exclusion Criteria (post Run-in phase):
- 1\) Unsuccessfully completed 1 week run-in phase. Defined as:
- Not using bimodal solution on 7 consecutive days during the run-in
- Not tolerating the increased UF anticipated with the bimodal solution. Tolerating 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)
Key Trial Info
Start Date :
September 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01242904
Start Date
September 30 2010
End Date
February 28 2015
Last Update
August 28 2017
Active Locations (1)
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1
London Health Sciences Centre, South Street Hospital, Peritoneal Dialysis Unit
London, Ontario, Canada, N6A 5W9