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CompletedNCT04394780Updated May 19, 2020

Peritoneal Dialysis Fluid Cooling and Cardio-Protective Effects

An interventional study of cooling in Dialysis; Complications, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-05-19.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Jan 2016, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dialysis; Complications

Keywords

  • cooling
  • peritoneal dialysis
  • myocardial perfusion
  • myocardial heterogeneity
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In context

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • 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

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.

06

What researchers measure

Primary outcomes

  1. Correlation between occlusive coronary artery disease and myocardial perfusion

    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

    Time frame: The day of study visit 1, lasting for approximately 2 hours

  2. Correlation between occlusive coronary artery disease and myocardial perfusion

    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

    Time frame: The day of study visit 2, lasting for approximately 6 hours

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Kalantar-Zadeh K, Block G, Humphreys MH, Kopple JD. Reverse epidemiology of cardiovascular risk factors in maintenance dialysis patients. Kidney Int. 2003 Mar;63(3):793-808. doi: 10.1046/j.1523-1755.2003.00803.x. PubMed 12631061 ↗
  • Burton JO, Jefferies HJ, Selby NM, McIntyre CW. Hemodialysis-induced cardiac injury: determinants and associated outcomes. Clin J Am Soc Nephrol. 2009 May;4(5):914-20. doi: 10.2215/CJN.03900808. Epub 2009 Apr 8. PubMed 19357245 ↗
  • Boon D, Bos WJ, van Montfrans GA, Krediet RT. Acute effects of peritoneal dialysis on hemodynamics. Perit Dial Int. 2001 Mar-Apr;21(2):166-71. PubMed 11330561 ↗
  • Drueke TB, Massy ZA. Atherosclerosis in CKD: differences from the general population. Nat Rev Nephrol. 2010 Dec;6(12):723-35. doi: 10.1038/nrneph.2010.143. Epub 2010 Oct 26. PubMed 20978469 ↗
  • McIntyre CW. Effects of hemodialysis on cardiac function. Kidney Int. 2009 Aug;76(4):371-5. doi: 10.1038/ki.2009.207. Epub 2009 Jun 10. PubMed 19516249 ↗
  • Ragosta M, Samady H, Isaacs RB, Gimple LW, Sarembock IJ, Powers ER. Coronary flow reserve abnormalities in patients with diabetes mellitus who have end-stage renal disease and normal epicardial coronary arteries. Am Heart J. 2004 Jun;147(6):1017-23. doi: 10.1016/j.ahj.2003.07.029. PubMed 15199350 ↗
  • Selby NM, Fialova J, Burton JO, McIntyre CW. The haemodynamic and metabolic effects of hypertonic-glucose and amino-acid-based peritoneal dialysis fluids. Nephrol Dial Transplant. 2007 Mar;22(3):870-9. doi: 10.1093/ndt/gfl654. Epub 2006 Nov 22. PubMed 17121785 ↗
  • Verbeke F, Van Biesen W, Pletinck A, Van Bortel LM, Vanholder R. Acute central hemodynamic effects of a volume exchange in peritoneal dialysis. Perit Dial Int. 2008 Mar-Apr;28(2):142-8. PubMed 18332449 ↗
  • Selby NM, Fonseca S, Hulme L, Fluck RJ, Taal MW, McIntyre CW. Automated peritoneal dialysis has significant effects on systemic hemodynamics. Perit Dial Int. 2006 May-Jun;26(3):328-35. PubMed 16722025 ↗
  • Barnes E, Dutka DP, Khan M, Camici PG, Hall RJ. Effect of repeated episodes of reversible myocardial ischemia on myocardial blood flow and function in humans. Am J Physiol Heart Circ Physiol. 2002 May;282(5):H1603-8. doi: 10.1152/ajpheart.00786.2001. PubMed 11959621 ↗
  • McIntyre CW, Burton JO, Selby NM, Leccisotti L, Korsheed S, Baker CS, Camici PG. Hemodialysis-induced cardiac dysfunction is associated with an acute reduction in global and segmental myocardial blood flow. Clin J Am Soc Nephrol. 2008 Jan;3(1):19-26. doi: 10.2215/CJN.03170707. Epub 2007 Nov 14. PubMed 18003765 ↗
  • Burton JO, Jefferies HJ, Selby NM, McIntyre CW. Hemodialysis-induced repetitive myocardial injury results in global and segmental reduction in systolic cardiac function. Clin J Am Soc Nephrol. 2009 Dec;4(12):1925-31. doi: 10.2215/CJN.04470709. Epub 2009 Oct 1. PubMed 19808220 ↗
  • Erlinge D. A Review of Mild Hypothermia as an Adjunctive Treatment for ST-Elevation Myocardial Infarction. Ther Hypothermia Temp Manag. 2011;1(3):129-41. doi: 10.1089/ther.2011.0008. PubMed 24717042 ↗
  • Gotberg M, Olivecrona GK, Engblom H, Ugander M, van der Pals J, Heiberg E, Arheden H, Erlinge D. Rapid short-duration hypothermia with cold saline and endovascular cooling before reperfusion reduces microvascular obstruction and myocardial infarct size. BMC Cardiovasc Disord. 2008 Apr 10;8:7. doi: 10.1186/1471-2261-8-7. PubMed 18402663 ↗
  • Chopp M, Knight R, Tidwell CD, Helpern JA, Brown E, Welch KM. The metabolic effects of mild hypothermia on global cerebral ischemia and recirculation in the cat: comparison to normothermia and hyperthermia. J Cereb Blood Flow Metab. 1989 Apr;9(2):141-8. doi: 10.1038/jcbfm.1989.21. PubMed 2921288 ↗
  • Jefferies HJ, Burton JO, McIntyre CW. Individualised dialysate temperature improves intradialytic haemodynamics and abrogates haemodialysis-induced myocardial stunning, without compromising tolerability. Blood Purif. 2011;32(1):63-8. doi: 10.1159/000324199. Epub 2011 Feb 24. PubMed 21346338 ↗
  • 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. PubMed 25964310 ↗
  • Eldehni MT, Odudu A, McIntyre CW. Randomized clinical trial of dialysate cooling and effects on brain white matter. J Am Soc Nephrol. 2015 Apr;26(4):957-65. doi: 10.1681/ASN.2013101086. Epub 2014 Sep 18. PubMed 25234925 ↗

Individual participant data

Plan to share: No — We don't share participant data with other researchers except our team

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04394780
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Responsible party
Chris McIntyre (Principal Investigator, London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
May 19, 2020
Start date
Jan 11, 2016
Primary completion
Jul 18, 2018
Completion
Dec 18, 2019
Last update
May 19, 2020

Study contacts

Christopher W McIntyre, MD
principal investigator · Western University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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