Use of a Bimodal Solution for Peritoneal Dialysis

End Stage Renal Disease Clinical Trial

Official title:

Randomized Controlled Trial of Bimodal Solution for Peritoneal Dialysis: 24-Hour UF Efficiency Using Bimodal PD Solutions During the Long Dwell

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242904
• Other study ID #: R-10-460
• Secondary ID: 17193
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2010
• Last updated: August 25, 2017
• Start date: September 30, 2010
• Est. completion date: February 28, 2015

Study information

• Verified date: August 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 28, 2015
• Est. primary completion date: February 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• bimodal solution
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
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

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, South Street Hospital, Peritoneal Dialysis Unit	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Baxter Healthcare Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.; 24-hour net ultrafiltration (in mL) is recorded automatically by the Automated Peritoneal Dialysis (APD) cycler.; 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.; 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
Secondary	24-hour urine volume		Calculated at baseline and at the end of the 6 week intervention period
Secondary	24-hour net sodium removal (in both peritoneal effluent and urine)		Calculated at baseline and at the end of the 6 week intervention period
Secondary	Volume measures as calculated by bioimpedance analysis		Calculated at baseline and at the end of the 6 week intervention period
Secondary	Weight	Used as an indicator of fluid retention	Calculated at baseline and at the end of the 6 week intervention period
Secondary	Mean and pulse arterial pressure		Calculated at baseline and at the end of the 6 week intervention period
Secondary	Number of anti-hypertensive agents		Calculated at baseline and at the end of the 6 week intervention period
Secondary	Renal (urine) solute clearance (Sodium, Urea, Creatinine)		Calculated at baseline and at the end of the 6 week intervention period
Secondary	Peritoneal effluent solute clearance (Sodium, Urea, Creatinine)		Calculated at baseline and at the end of the 6 week intervention period