Clinical trial NCT04394780: Peritoneal Dialysis Fluid Cooling and Cardio-Protective Effects
Official title: Pilot Study to Determine Whether Cooled Peritoneal Dialysis Fluid Confers Cardio-Protective Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dialysis; Complications
Keywords: cooling
peritoneal dialysis
myocardial perfusion
myocardial heterogeneity
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 8
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Every patient underwent peritoneal dialysis at 37 C and then at 32 C one week after.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation between occlusive coronary artery disease and myocardial perfusion
timeFrame: The day of study visit 1, lasting for approximately 2 hours
measure: Correlation between occlusive coronary artery disease and myocardial perfusion
timeFrame: The day of study visit 2, lasting for approximately 6 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Western University
name: Christopher W McIntyre, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Odudu A, Eldehni MT, McCann GP, McIntyre CW. Randomized Controlled Trial of Individualized Dialysate Cooling for Cardiac Protection in Hemodialysis Patients. Clin J Am Soc Nephrol. 2015 Aug 7;10(8):1408-17. doi: 10.2215/CJN.00200115. Epub 2015 May 11.
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