Dialysis; ComplicationsNCT04394780
Peritoneal Dialysis Fluid Cooling and Cardio-Protective Effects
A study testing cooling in people with Dialysis; Complications, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dialysis; Complications
- What is being tested?
- cooling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2016to 18 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Dialysis; Complications
- Being tested
- cooling
- Keywords
- cooling, peritoneal dialysis, myocardial perfusion, myocardial heterogeneity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coolingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal dialysis at 37 C | No intervention | Patients underwent peritoneal dialysis with the standard temperature. |
| Peritoneal dialysis at 32 C | Active comparator | 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. Receives: Procedure: cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The day of study visit 1, lasting for approximately 2 hours
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
Measured: The day of study visit 2, lasting for approximately 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start11 Jan 2016
- Primary completion18 Jul 2018
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Dialysis; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Every patient underwent peritoneal dialysis at 37 C and then at 32 C one week after.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Christopher W McIntyre, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394780
- Sponsor's protocol ID
- 107280
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't share participant data with other researchers except our team
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 12631061Burton 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 19357245Boon 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 11330561Drueke 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 20978469McIntyre 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 19516249Ragosta 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 15199350Selby 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 17121785Verbeke 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 18332449Selby 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 16722025Barnes 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 11959621McIntyre 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 18003765Burton 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 19808220Erlinge 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 24717042Gotberg 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 18402663Chopp 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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Determine Whether Cooled Peritoneal Dialysis Fluid Confers Cardio-Protective Effects
- ClinicalTrials.gov ID
- NCT04394780
- Acronym / sponsor ID
- 107280
- Conditions
- Dialysis; Complications
- Keywords
- cooling, peritoneal dialysis, myocardial perfusion, myocardial heterogeneity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Every patient underwent peritoneal dialysis at 37 C and then at 32 C one week after.
| Arm | Type | Receives |
|---|---|---|
| Peritoneal dialysis at 37 C | No intervention | –Patients underwent peritoneal dialysis with the standard temperature. |
| Peritoneal dialysis at 32 C | Active comparator | Procedure: coolingPatients 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coolingFirst, 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. | Procedure or surgery | Peritoneal dialysis at 32 C |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Results publication: PubMed 12631061Kalantar-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.
- Results publication: PubMed 19357245Burton 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.
- Results publication: PubMed 11330561Boon 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.
- Results publication: PubMed 20978469Drueke 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.
- Results publication: PubMed 19516249McIntyre 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.
- Results publication: PubMed 15199350Ragosta 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.
- Results publication: PubMed 17121785Selby 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.
- Results publication: PubMed 18332449Verbeke 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.
- Results publication: PubMed 16722025Selby 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.
- Results publication: PubMed 11959621Barnes 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.
- Results publication: PubMed 18003765McIntyre 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.
- Results publication: PubMed 19808220Burton 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.
- Individual participant dataSharing planned: No. We don't share participant data with other researchers except our team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher W McIntyre, MD principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A study testing cooling in people with Dialysis; Complications, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between occlusive coronary artery disease and myocardial perfusion (time frame: The day of study visit 1, lasting for approximately 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04394780, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.