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Clinical Trial Details

Trial ID: L0739
Source ID: NCT05185999
Associated Drug: Icodextrin/Dextrose
Title: Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Failure
Interventions: DRUG: Icodextrin/Dextrose
Outcome Measures: Primary: 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., 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., 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., 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), 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., 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., 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., 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., Throughout the study visit - approximately 9 hours | Secondary: 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., 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., 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., Throughout the study visit - approximately 9 hours
Sponsor/Collaborators: Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2022-10-17
Completion Date: 2023-10-20
Results First Posted:
Last Update Posted: 2024-01-29
Locations: Victoria Hospital, London Health Sciences Centre, London, Ontario, N6A 5W9, Canada|Westmount Kidney Care Centre, London, Ontario, N6K 1M6, Canada
URL: https://clinicaltrials.gov/show/NCT05185999