Peritoneal Dialysis Fluid Cooling and Cardio-Protective Effects

Lawson Health Research Institute

Status: Completed

Conditions: Dialysis; Complications

Treatments: Procedure: cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT04394780

107280

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Peritoneal dialysis at 37 C

No Intervention group

Description:

Patients underwent peritoneal dialysis with the standard temperature.

Peritoneal dialysis at 32 C

Active Comparator group

Description:

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.

Treatment:

Procedure: cooling