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NCT Number: NCT01242904

Use of a Bimodal Solution for Peritoneal Dialysis

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

London, Ontario, N6A 5W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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):

  • 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)

Treatment and study plan

bimodal solution

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

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

Primary outcomes

  1. net ultrafiltration efficiency in mL/g

    Time frame: Calculated at baseline and at the end of the 6 week intervention period

    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)

Secondary outcomes

  1. 24-hour absolute total carbohydrate absorption

    Time frame: Calculated at baseline and at the end of the 6 week intervention period

    This will include both glucose and icodextrin absorption.

  2. 24-hour urine volume

    Time frame: Calculated at baseline and at the end of the 6 week intervention period

  3. 24-hour net sodium removal (in both peritoneal effluent and urine)

    Time frame: Calculated at baseline and at the end of the 6 week intervention period

  4. Volume measures as calculated by bioimpedance analysis

    Time frame: Calculated at baseline and at the end of the 6 week intervention period

  5. Weight

    Time frame: Calculated at baseline and at the end of the 6 week intervention period

    Used as an indicator of fluid retention

  6. Mean and pulse arterial pressure

    Time frame: Calculated at baseline and at the end of the 6 week intervention period

  7. Number of anti-hypertensive agents

    Time frame: Calculated at baseline and at the end of the 6 week intervention period

  8. Renal (urine) solute clearance (Sodium, Urea, Creatinine)

    Time frame: Calculated at baseline and at the end of the 6 week intervention period

  9. Peritoneal effluent solute clearance (Sodium, Urea, Creatinine)

    Time frame: Calculated at baseline and at the end of the 6 week intervention period

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2010
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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