Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients

NCT ID: NCT05185999

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2023-10-20

Brief Summary

Patients with kidney failure rely on dialysis for sodium and fluid removal. The importance of a sodium and fluid balance in patients with kidney disease is very important. Excess volume has been consistently associated with cardiovascular morbidity and mortality.

Many peritoneal dialysis (PD) patients need large volumes of dextrose or Icodextrin based solutions to achieve fluid removal. Commonly used PD solutions also have high sodium concentrations to limit sugar absorption. These PD fluids can reduce the amount of sodium removed and may eventually lead to water retention over time with possible adverse outcomes.

This research study is being conducted to determine if a single eight-hour dwell of intraperitoneal sodium-free 30% Icodextrin / 10% Dextrose solution is safe, tolerable and effective in achieving sodium and volume removal in PD patients.

Detailed Description

This study is a phase 1 interventional study in Peritoneal Dialysis Patients. Investigators will recruit 10 participants. This study involves one visit at the London Health Sciences Centre University Hospital lasting approximately 9 hours.

Study participants will receive one in-center PD dwell, consisting of peritoneal instillation of a sodium-free 30% Icodextrin/10% dextrose solution via their Tenckhoff catheter; the solution will be dwelling in the study participant's peritoneal cavity for a maximum of 8 hours as tolerated, at the end of which the solution will be drained.

Participants will be monitored during administration of the study solution, during dwell and up to one hour after the Peritoneal Dialysis fluid is drained.

Study participants will also undergo:

• Clinical blood pressure and heart rate monitoring: baseline + every 15 minutes for the first two hours; then every 30 minutes up until 1 hour post complete peritoneal solution drain
• Continuous Finapress hemodynamic monitoring (until 1 hour post peritoneal solution drain)
• Pain Monitoring throughout the study visit (Five point verbal scale and McGill Pain Questionnaire)
• Blood collection: baseline, 1, 2, 4, 8 hours into the dwell and 1 hour after the end of drain
• Peritoneal dialysate collection: 1, 2, 4, 8 hours into the dwell
• Urine collection throughout visit.

Conditions

Chronic Kidney Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Intraperitoneal infusion with 500 mL of sodium-free 30% Icodextrin/ 10% Dextrose solution

Group Type: EXPERIMENTAL

Icodextrin/Dextrose

Intervention Type: DRUG

Single 8 hour dwell of a 500mL intraperitoneal sodium-free 30% Icodextrin / 10% Dextrose solution

Interventions

Icodextrin/Dextrose

Single 8 hour dwell of a 500mL intraperitoneal sodium-free 30% Icodextrin / 10% Dextrose solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Functioning Tenckhoff catheter
• Stable PD prescription regimen (continuous ambulatory PD or automated PD) for the past month
• Age 18 years or older
• Willing and able to provide informed consent
• Able to Speak and Read English

Exclusion Criteria

• Type 1 or uncontrolled diabetes mellitus
• Active infections
• Pre-study serum sodium <130 mmol/L
• Serum bicarbonate < 18mmol/L
• Patients with standard PD prescriptions relying exclusively on lowest glucose containing fluid
• Allergy to starch-based polymers (e.g. corn starch) and/or icodextrin
• Intolerance to maltose or isomaltose
• Glycogen storage disease
• Uncorrectable mechanical defects that prevent effective PD or increase the risk of infection
• Documented loss of peritoneal function or extensive adhesions that compromise peritoneal function

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

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Chris McIntyre

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher W McIntyre, MD/PHD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre - Victoria Hospital

Locations

Victoria Hospital, London Health Sciences Centre

London, Ontario, Canada

Westmount Kidney Care Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

119910

Identifier Type: -

Identifier Source: org_study_id