Peritoneal Dialysis Fluid Cooling and Cardio-Protective Effects

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study to Determine Whether Cooled Peritoneal Dialysis Fluid Confers Cardio-Protective Effects

Conditions
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Dialysis; Complications

Intervention / Treatment
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* Procedure: cooling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Every patient underwent peritoneal dialysis at 37 C and then at 32 C one week after.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Peritoneal dialysis at 37 C<br>Patients underwent peritoneal dialysis with the standard temperature. | |
| Active Comparator: Peritoneal dialysis at 32 C<br>Patients started on continuous ambulatory peritoneal dialysis using a peritoneal dialysate cooled to between 32-33 degrees centigrade, at a pre-determined and precisely controlled temperature for the 4 hour duration treatment. | Procedure: cooling<br>* First, patients underwent peritoneal dialysis (PD) at 37 C (standard temperature) and then patients underwent PD cooling. After each PD session, the patient had a CT scan for the study team to study myocardial perfusion at rest and after introduction of a pharmacological stressor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between occlusive coronary artery disease and myocardial perfusion | 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 | The day of study visit 1, lasting for approximately 2 hours | 
| Correlation between occlusive coronary artery disease and myocardial perfusion | 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 | The day of study visit 2, lasting for approximately 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cooling, peritoneal dialysis, myocardial perfusion, myocardial heterogeneity