Pilot Study to Determine Whether Cooled Peritoneal Dialysis Fluid Confers Cardio-Protective Effects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Primary Endpoint
- Correlation between occlusive coronary artery disease and myocardial perfusion
Study Overview
Brief Summary
The study team aimed to investigate the relationship between occlusive coronary artery disease, myocardial perfusion, and peritoneal dialysate temperature. In addition, the study team aimed to identify how abnormal myocardial perfusion in peritoneal dialysis (PD) patients is related to occlusive coronary artery disease, to identify factors associated with occlusive coronary artery disease in end-stage renal failure patients on PD. Finally, the study team identified factors associated with PD induced cardiac injury in end-stage renal failure patients on this dialysis modality.
In order to assess the patients response to physiological stress and the functional relevance of their coronary artery disease, patients underwent assessment using dual energy contrast enhanced (DCE) CT assessment of coronary arteries and myocardial perfusion. An initial CT scan with administration of contrast established baseline information regarding the extent of coronary artery disease, fibrosis, and myocardial perfusion at rest. Following this, patients underwent pharmacological stress with the administration of adenosine and a repeat CT scan established the response to stress in terms of myocardial perfusion. On the second study visit patients were started on C-CAPD using peritoneal dialysate cooled to between 32-33 degrees centigrade, at a pre-determined and precisely controlled temperature for the 4 hour duration of C-CAPD. Subsequently, patients were injected with a pharmacological stressor in the form of adenosine. They then underwent DCE CT assessment of coronary arteries and myocardial perfusion as done in the first visit. The second CT scan took place following a PD dwell.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients having peritoneal dialysis treatment at least 6 times per week at home and followed at the London Health Sciences Centre
- •Male and female, age=16 years old
- •Patients listed for renal transplantation
- •Residual renal function less than or equal to 750 mls per 24 hour period
Exclusion Criteria
- •Not meeting inclusion criteria
- •Previous adverse reaction to intravenous contrast
- •Allergy to adenosine - Patients with significant residual renal function (greater than 750mL/24 hours)
- •Exposure to peritoneal dialysis for <90 days prior to recruitment
- •Ongoing spontaneous bacterial peritonitis (SBP)
- •Severe heart failure (New York Heart Association grade IV) - Cardiac transplant recipients
- •Mental incapacity to consent
Outcomes
Primary Outcomes
Correlation between occlusive coronary artery disease and myocardial perfusion
Time Frame: The day of study visit 2, lasting for approximately 6 hours
Investigate the correlation between occlusive coronary artery disease, myocardial perfusion and peritoneal dialysate temperature. Patients will have a CT scan to measure perfusion (mL/min/g) after peritoneal dialysis
Secondary Outcomes
No secondary outcomes reported
Investigators
Chris McIntyre
Principal Investigator
Lawson Health Research Institute