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Peritoneal Dialysis Fluid Cooling and Cardio-Protective Effects

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04394780
Enrollment
8
Registered
2020-05-19
Start date
2016-01-11
Completion date
2019-12-18
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis; Complications

Keywords

cooling, peritoneal dialysis, myocardial perfusion, myocardial heterogeneity

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.

Interventions

PROCEDUREcooling

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.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Every patient underwent peritoneal dialysis at 37 C and then at 32 C one week after.

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between occlusive coronary artery disease and myocardial perfusionThe day of study visit 1, lasting for approximately 2 hoursInvestigate 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026