Clinical trial NCT01242904: Use of a Bimodal Solution for Peritoneal Dialysis
Official title: Randomized Controlled Trial of Bimodal Solution for Peritoneal Dialysis: 24-Hour UF Efficiency Using Bimodal PD Solutions During the Long Dwell
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: dialysis solutions
renal replacement therapy
peritoneal dialysis
bimodal solution
glucose sparing therapy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2010-11-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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 least one exchange overnight in at least 5 out of 7 days
5. Have residual urine volume \<800 ml/24 hours
6. Long dwell must be or patient must tolerate at least an 8-10 hr long dwell.

Exclusion Criteria:

1. Scheduled Transplant in the next 1 year
2. Life expectancy \< 3 mo (estimated by physician)
3. Participating in other trial that could influence outcome of this trial
4. Known icodextrin allergy
5. Currently using non-Baxter PD solutions
6. 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:

1. Not using bimodal solution on 7 consecutive days during the run-in
2. 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)

Primary outcomes:
measure: net ultrafiltration efficiency in mL/g
timeFrame: Calculated at baseline and at the end of the 6 week intervention period
Secondary outcomes:
measure: 24-hour absolute total carbohydrate absorption
timeFrame: Calculated at baseline and at the end of the 6 week intervention period
measure: 24-hour urine volume
timeFrame: Calculated at baseline and at the end of the 6 week intervention period
measure: 24-hour net sodium removal (in both peritoneal effluent and urine)
timeFrame: Calculated at baseline and at the end of the 6 week intervention period
measure: Volume measures as calculated by bioimpedance analysis
timeFrame: Calculated at baseline and at the end of the 6 week intervention period
measure: Weight
timeFrame: Calculated at baseline and at the end of the 6 week intervention period
measure: Mean and pulse arterial pressure
timeFrame: Calculated at baseline and at the end of the 6 week intervention period
measure: Number of anti-hypertensive agents
timeFrame: Calculated at baseline and at the end of the 6 week intervention period
measure: Renal (urine) solute clearance (Sodium, Urea, Creatinine)
timeFrame: Calculated at baseline and at the end of the 6 week intervention period
measure: Peritoneal effluent solute clearance (Sodium, Urea, Creatinine)
timeFrame: Calculated at baseline and at the end of the 6 week intervention period
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre, South Street Hospital, Peritoneal Dialysis Unit
state: Ontario
Study officials:
affiliation: London Health Sciences Centre, Dept of Medicine, Victoria Campus, London Ontario
name: Arsh K Jain, MD
role: PRINCIPAL_INVESTIGATOR
References: