Peritoneal Dialysis Fluid Cooling and Cardio-Protective Effects

May 15, 2020 updated by: Chris McIntyre, Lawson Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Peritoneal dialysis at 37 C
Patients underwent peritoneal dialysis with the standard temperature.
ACTIVE_COMPARATOR: Peritoneal dialysis at 32 C
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 11, 2016

Primary Completion (ACTUAL)

July 18, 2018

Study Completion (ACTUAL)

December 18, 2019

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (ACTUAL)

May 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 107280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We don't share participant data with other researchers except our team

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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