Use of a Bimodal Solution for Peritoneal Dialysis

NCT ID: NCT01242904

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-02-28

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

bimodal solution

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

Group Type: EXPERIMENTAL

bimodal solution

Intervention Type: 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

200 mls of icodextrin is added by the patient to the usual icodextrin day dwell

Group Type: ACTIVE_COMPARATOR

icodextrin

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arsh K Jain, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre, Dept of Medicine, Victoria Campus, London Ontario

Locations

London Health Sciences Centre, South Street Hospital, Peritoneal Dialysis Unit

London, Ontario, Canada

Countries

Canada

Other Identifiers

17193

Identifier Type: OTHER

Identifier Source: secondary_id

R-10-460

Identifier Type: -

Identifier Source: org_study_id