Clinical Trials Directory

Trials / Completed

CompletedNCT04394780

Peritoneal Dialysis Fluid Cooling and Cardio-Protective Effects

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcoolingFirst, 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.

Timeline

Start date
2016-01-11
Primary completion
2018-07-18
Completion
2019-12-18
First posted
2020-05-19
Last updated
2020-05-19

Source: ClinicalTrials.gov record NCT04394780. Inclusion in this directory is not an endorsement.