A Phase 1 interventional study of Icodextrin/Dextrose in Chronic Kidney Failure, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 1, Interventional, and Health services research
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.
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:
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 10 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
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Exclusion Criteria:
Intraperitoneal infusion with 500 mL of sodium-free 30% Icodextrin/ 10% Dextrose solution
Drug: Icodextrin/Dextrose
Single 8 hour dwell of a 500mL intraperitoneal sodium-free 30% Icodextrin / 10% Dextrose solution
Number of participants with treatment related Adverse Events or Serious Adverse Events.
Adverse Events and Serious Adverse Events will help determine the safety of the intraperitoneal solution. Change in symptoms from baseline.
Time frame: Throughout the study visit - approximately 9 hours
Changes in hemodynamic stability (Blood Pressure)
This will determine participant tolerability of the treatment. Systolic and Diastolic blood pressure (mm/Hg) will be measured throughout the study visit at baseline, every 15 minutes for 2 hours, then every 30 minutes until 1 hour after solution drain is complete. If the systolic or diastolic blood pressure changes more then 40 mmHg or more at any time point the study physician will be consulted for direction.
Time frame: Throughout the study visit - approximately 9 hours
Changes in hemodynamic stability (Heart Rate)
This will determine participant tolerability of the treatment. We will monitor heart rate (bpm) at baseline, every 15 minutes for 2 hours, then every 30 minutes until 1 hour after solution drain is complete. If heart rate is less then 50 beats per minute or greater then 120 beats per minute the study physician will be alerted.
Time frame: Throughout the study visit - approximately 9 hours
Changes in hemodynamic stability (Finapres monitoring)
This will determine tolerability of the treatment. Hemodynamic monitoring using Finapres (finger-cuff to detect beat-to-beat changes) Hemodynamic variables such as pulse rate, blood pressure, stroke volume, cardiac output, and total peripheral resistance are derived. (for post hoc observational analysis only)
Time frame: Throughout the study visit - approximately 9 hours
Sodium Removal
This will measure the efficacy of the treatment. Serum sodium (mmol/L) levels will be drawn at baseline, 1, 2, 4, 8 and 9 hours and sent to the lab for analysis.
Time frame: Throughout the study visit - approximately 9 hours
Pain Assessment (Five-point Verbal Scale)
This pain assessment will determine tolerability of the treatment. Five-point Verbal Scale (0-no pain, 1=mild pain, 2=moderate pain, 3=severe pain, 4=very severe pain) We will complete the Five-point Verbal Scale at the following time points: * start of infusion at 1, 3, and 5 minutes after start of infusion and at end of infusion of the Icodextrin/Dextrose solution * 15, 30 minutes into dwell, hourly during dwell and at the end of dwell of the Icodextrin/Dextrose solution * start of drain, 5 minutes into drain and end of drain of the Icodextrin/Dextrose solution If Five-Point verbal scale \>3 for two consecutive readings and if pain exceeds individual tolerability, fluid will be drained and the study physician will be alerted.
Time frame: Throughout the study visit - approximately 9 hours
Pain Assessment (McGill Pain Questionnaire)
This pain assessment will determine tolerability of the treatment. McGill Pain Questionnaire (MPQ) 30 minutes into dwell of the Icodextrin/Dextrose solution The MPQ explores the multi-dimensional nature of pain.
Time frame: Throughout the study visit - approximately 9 hours
Ultrafiltration Volume
This will measure the efficacy of the treatment. Ultrafiltrate will be measured in litres post drain.
Time frame: Throughout the study visit - approximately 9 hours
Serum Glucose monitoring and glucose absorption
This will measure glucose (mmol/L) levels will be drawn at baseline, 1, 2, 4, 8 and 9 hours and sent to the lab for analysis.
Time frame: Throughout the study visit - approximately 9 hours
Dialysate icodextrin biproducts
This will measure the efficacy of the treatment. A 15 ml sample of peritoneal effluent will be collected at 1, 2, 4 and 8 hours in to dwell. This sample will be sent to the lab for the analysis of dialysate Icodextrin biproducts.
Time frame: Throughout the study visit - approximately 9 hours
Serum Icodextrin biproducts
This will measure the efficacy of the treatment. Serum will be collected at baseline, 1, 2, 4 and 8 and 9 hours and sent to lab for analysis of Icodextrin biproducts.
Time frame: Throughout the study visit - approximately 9 hours
Plan to share: No
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's