Haemodialysis ComplicationNCT02997774
Cooler Dialysis and Liver Perfusion and Function
A study testing Cooler dialysis and Standard Dialysis in people with Haemodialysis Complication, run by Chris McIntyre at 1 site in Canada.
Trial summary
Having hemodialysis affects the blood supply to various organs in the body including the heart and the brain. With time, these effects build up and can affect the way these organs function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodialysis Complication
- What is being tested?
- Cooler dialysis and Standard Dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 8 Feb 2017to 4 May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to provide informed consent
- Age greater than 18 years
- Hemodialysis for at least 3 months
- No significant residual renal function (<250mls urine/day)
Who cannot join
- Chronic liver disease of any stage
- Chronic intestinal disease excluding Irritable Bowel Syndrome (IBS)
- Previous liver transplant or liver resection
- Previous Transjugular Portosystemic Shunt (TIPSS) insertion
- Active infection or malignancy
- Pregnant, breastfeeding or intending pregnancy
Show all 9Show fewer
- Unable to give consent or understand written information
- Diabetic and experiencing hypoglycemia during dialysis within the last 2 months
- Known allergy/intolerance to contrast agent or iodides
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Cooler Dialysate on Liver Perfusion, Endotoxemia and Uremic Toxin Handling in Hemodialysis Patients
Having hemodialysis affects the blood supply to various organs in the body including the heart and the brain. With time, these effects build up and can affect the way these organs function. The investigators have previously shown that the liver (a key organ which works to help clean the blood, make proteins and turn all your food into energy) is also affected. One of the ways to help protect organs from injury due to dialysis has been cooling during dialysis. The investigators want to examine whether cooling during dialysis protects the blood supply to the liver. CT imaging will be used to measure this blood supply during hemodialysis with standard and cooler settings.
Read the detailed description
Hemodialysis exerts significant hemodynamic effects with widespread consequences on vulnerable vascular beds. Cardiac injury, including myocardial stunning and subclinical myocardial ischemia, appears to be common and associated with significantly increased mortality. The liver has been shown to have preserved blood flow due to its dual blood supply. Even so, the liver excretory function is decreased and endotoxin levels in the blood increase during hemodialysis. Extracorporeal cooling during dialysis has been associated with protective effects on the brain and heart of dialysis patients. The effects of cooler dialysis on liver perfusion, function and endotoxemia during hemodialysis is unknown.
The investigators therefore propose to use CT perfusion imaging to examine the effect of cooling during hemodialysis on liver perfusion, relating this effect to endotoxin translocation and myocardial dysfunction. Additionally, they intend to investigate the potential effects on hepatic function in this context, examining the relationship between liver perfusion and endotoxemia, the metabolism of uremic toxins and clinical symptoms of uremia.
This is a prospective randomized cross-over study involving a single center recruiting patients from the prevalent dialysis population of London Health Sciences Centre (LHSC) Renal Program. Once recruited, patients will undergo two study hemodialysis sessions - one will use standard dialysate temperature of 36.5 degrees Celsius (HD36.5) and one will use cooler dialysate temperature at 35 degrees Celsius (HD35). The order of these two sessions will be randomly allocated. Before, during and after each session, participants will undergo cardiac and hepatic assessment. This will include CT scans, 2D echocardiography and indocyanine green (ICG) clearance measurements. In addition, participants will answer a number of questionnaires about uremic symptoms and blood tests will also be done.
The investigators' aim is to characterize and compare liver function and perfusion before during and after hemodialysis, with standard and cooler dialysate temperature.
- Conditions
- Haemodialysis Complication
- Being tested
- Cooler dialysis, Standard Dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooler dialysisOther
Having dialysis at a slightly cooler temperature (35 vs 36.5 degrees Celsius)
Standard DialysisOther
Having dialysis at a standard temperature (36.5 degrees Celsius)
| Study group | Role | What they receive |
|---|---|---|
| Standard Dialysis | Active comparator | Patient will undergo dialysis at 36.5 degrees Celsius to assess if this affects the liver function and perfusion Receives: Other: Standard Dialysis |
| Cooler Dialysis | Experimental | Patient will undergo dialysis at 35 degrees Celsius to assess if this affects the liver function and perfusion Receives: Other: Cooler dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in regional liver perfusion in mls/min/100g from baseline to peak stress during dialysis (3 hours into the dialysis session) with standard versus cooler dialysate temperature.
Measured: 2 years
Secondary outcomes (8)
Change in global liver perfusion in mls/min/100g pre, during and post-dialysis with cooler dialysate
Measured: 2 years
ICG clearance rate pre, during and post-dialysis with cooler vs standard dialysate
Measured: 2 years
Contribution of portal venous flow to hepatic perfusion (PV fraction) pre, during and post-dialysis with cooler vs standard dialysate
Measured: 2 years
Endotoxin levels with cooler vs standard dialysate
Measured: 2 years
Troponin T levels with cooler vs standard dialysate
Measured: 2 years
Number of stunned myocardial segments with cooler vs standard dialysate
Measured: 2 years
Uremic toxin levels with cooler vs standard dialysate
Measured: 2 years
Uremic symptom scores with cooler vs standard dialysate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start8 Feb 2017
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemodialysis ComplicationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chris McIntyre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Chris W McIntyre, PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997774
- Sponsor's protocol ID
- 108616
- Status last verified
- Aug 2018
- First submitted
- 16 Dec 2016
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Cooler Dialysate on Liver Perfusion, Endotoxemia and Uremic Toxin Handling in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02997774
- Acronym / sponsor ID
- 108616
- Conditions
- Haemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chris McIntyreUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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.
Having hemodialysis affects the blood supply to various organs in the body including the heart and the brain. With time, these effects build up and can affect the way these organs function. The investigators have previously shown that the liver (a key organ which works to help clean the blood, make proteins and turn all your food into energy) is also affected. One of the ways to help protect organs from injury due to dialysis has been cooling during dialysis. The investigators want to examine whether cooling during dialysis protects the blood supply to the liver. CT imaging will be used to measure this blood supply during hemodialysis with standard and cooler settings.
Detailed description
Hemodialysis exerts significant hemodynamic effects with widespread consequences on vulnerable vascular beds. Cardiac injury, including myocardial stunning and subclinical myocardial ischemia, appears to be common and associated with significantly increased mortality. The liver has been shown to have preserved blood flow due to its dual blood supply. Even so, the liver excretory function is decreased and endotoxin levels in the blood increase during hemodialysis. Extracorporeal cooling during dialysis has been associated with protective effects on the brain and heart of dialysis patients. The effects of cooler dialysis on liver perfusion, function and endotoxemia during hemodialysis is unknown.
The investigators therefore propose to use CT perfusion imaging to examine the effect of cooling during hemodialysis on liver perfusion, relating this effect to endotoxin translocation and myocardial dysfunction. Additionally, they intend to investigate the potential effects on hepatic function in this context, examining the relationship between liver perfusion and endotoxemia, the metabolism of uremic toxins and clinical symptoms of uremia.
This is a prospective randomized cross-over study involving a single center recruiting patients from the prevalent dialysis population of London Health Sciences Centre (LHSC) Renal Program. Once recruited, patients will undergo two study hemodialysis sessions - one will use standard dialysate temperature of 36.5 degrees Celsius (HD36.5) and one will use cooler dialysate temperature at 35 degrees Celsius (HD35). The order of these two sessions will be randomly allocated. Before, during and after each session, participants will undergo cardiac and hepatic assessment. This will include CT scans, 2D echocardiography and indocyanine green (ICG) clearance measurements. In addition, participants will answer a number of questionnaires about uremic symptoms and blood tests will also be done.
The investigators' aim is to characterize and compare liver function and perfusion before during and after hemodialysis, with standard and cooler dialysate temperature.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dialysis | Active comparator | Other: Standard DialysisPatient will undergo dialysis at 36.5 degrees Celsius to assess if this affects the liver function and perfusion |
| Cooler Dialysis | Experimental | Other: Cooler dialysisPatient will undergo dialysis at 35 degrees Celsius to assess if this affects the liver function and perfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be able to provide informed consent
- Age greater than 18 years
- Hemodialysis for at least 3 months
- No significant residual renal function (<250mls urine/day)
Key exclusion criteria (9 listed)
- Chronic liver disease of any stage
- Chronic intestinal disease excluding Irritable Bowel Syndrome (IBS)
- Previous liver transplant or liver resection
- Previous Transjugular Portosystemic Shunt (TIPSS) insertion
- Active infection or malignancy
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 |
|---|---|---|
| Cooler dialysisHaving dialysis at a slightly cooler temperature (35 vs 36.5 degrees Celsius) | Other | Cooler Dialysis |
| Standard DialysisHaving dialysis at a standard temperature (36.5 degrees Celsius) | Other | Standard Dialysis |
Primary outcome
Change in regional liver perfusion in mls/min/100g from baseline to peak stress during dialysis (3 hours into the dialysis session) with standard versus cooler dialysate temperature.
Time frame: 2 years
8 secondary outcomes
Change in global liver perfusion in mls/min/100g pre, during and post-dialysis with cooler dialysate
Time frame: 2 years
ICG clearance rate pre, during and post-dialysis with cooler vs standard dialysate
Time frame: 2 years
Contribution of portal venous flow to hepatic perfusion (PV fraction) pre, during and post-dialysis with cooler vs standard dialysate
Time frame: 2 years
Endotoxin levels with cooler vs standard dialysate
Time frame: 2 years
Troponin T levels with cooler vs standard dialysate
Time frame: 2 years
Number of stunned myocardial segments with cooler vs standard dialysate
Time frame: 2 years
Uremic toxin levels with cooler vs standard dialysate
Time frame: 2 years
Uremic symptom scores with cooler vs standard dialysate
Time frame: 2 years
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 17 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Chris W McIntyre, PhD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooler dialysis and Standard Dialysis in people with Haemodialysis Complication, run by Chris McIntyre at 1 site in Canada.
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 9 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in regional liver perfusion in mls/min/100g from baseline to peak stress during dialysis (3 hours into the dialysis session) with standard versus cooler dialysate temperature. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2018; AzTrials last refreshed its copy on 30 Oct 2026.