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| ID | Type | Description | Link |
|---|---|---|---|
| IRAS 207142 | Other Grant/Funding Number | Health Research Authority UK |
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The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques. The effects of a standard prescription haemodialysis (dialysate temperature 37 C) will be compared to a thermocontrolled (or isothermic) haemodialysis prescription to ascertain if thermocontrolled HD provides a protective effect on organ perfusion and circulatory stress when compared to conventional haemodialysis. The BTM (blood temperature monitor, Fresenius) offers a way to overcome this to regulate thermal balance during dialysis and achieve a neutral thermal balance (isothermic) over the dialysis session. Other dialysis parameters will be standardised between treatment arms using blood volume monitoring (BVM) and clinical assessments.
The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques. The Primary objectives are to investigate the difference in cardiac perfusion, structure and function between standard HD and thermocontrolled HD using magnetic imaging techniques, to observe the the changes in renal perfusion and oxygenation within one dialysis session and the changes to cerebral perfusion within one dialysis session.
The secondary objectives are to investigate the difference in cerebral perfusion, structure, oedema and function between standard HD and thermocontrolled HD, the difference in renal perfusion and oxygenation between standard HD and thermocontrolled HD and the differences in visual acuity and cognitive assessment across a dialysis session and over a dialysis treatment course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard HD | Experimental | HD with constant temperature of 37°C, MRI scans of the heart, kidneys and brain during HD sessions |
|
| Thermocontrolled HD | Experimental | HD applying the Blood Temperature Monitor (BTM), MRI scans of the heart, kidneys and brain during HD sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HD, Magnetic Resonance Imaging (MRI) scans | Other | HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiac output during standard HD and thermocontrolled HD | Change in cardiac output during standard HD and thermocontrolled HD using Phase Contrast Magnetic Resonance Imaging (PC-MRI) | after 2 and 4 weeks after randomisation |
| Change in renal perfusion during standard HD and thermocontrolled HD | Change in renal perfusion using Arterial Spin Labelling (ASL) and renal artery flow using PC-MRI | after 2 and 4 weeks after randomisation |
| Change in cerebral perfusion during standard HD and thermocontrolled HD | Change in cerebral perfusion during standard HD and thermocontrolled HD using ASL | after 2 and 4 weeks after randomisation |
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Exclusion Criteria:
Change in dry weight (clinically defined) in 4 weeks prior to recruitment
Dialysate composition other than: sodium≥137mmol/L, potassium≥2.0mmol/L, calcium≥1.5mmol/L, magnesium≥0.5mmol/L, glucose 1.0g/L
Instability on dialysis in 4 weeks prior to recruitment leading to either:
Dialysed via a synthetic line, central venous catheter or graft
Qa < 500ml/min
NYHA Stage IV heart failure (New York Heart Association)
Active infection or malignancy
Contraindication to MRI scanning including claustrophobia, pacemaker, metallic implants etc
Pregnancy (pregnancy test will be conducted with female patients aged ≤ 55 years) or planning pregnancy or lactation period
Medical conditions or overall physical frailty precludes scan session in opinion of investigator
Unable or unwilling to provide informed consent
Any condition which could interfere with the patient's ability to comply with the study
Participation in an interventional clinical study during the preceding 30 days
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarten Taal, Professor | University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine | Study Chair |
| Nicolas Selby, Dr | University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine | Nottingham | United Kingdom |
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monocentric, block randomized, open, crossover study
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D002318 | Cardiovascular Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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