An interventional study of HD, Magnetic Resonance Imaging (MRI) scans in Renal Failure, Cardiovascular Diseases and Congenital Disorders, sponsored by Fresenius Medical Care Deutschland GmbH. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-15.
Sponsored by Fresenius Medical Care Deutschland GmbH · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Instability on dialysis in 4 weeks prior to recruitment leading to either:
Inclusion Criteria:
HD with constant temperature of 37°C, MRI scans of the heart, kidneys and brain during HD sessions
Other: HD, Magnetic Resonance Imaging (MRI) scans
HD applying the Blood Temperature Monitor (BTM), MRI scans of the heart, kidneys and brain during HD sessions
Other: HD, Magnetic Resonance Imaging (MRI) scans
HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions
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)
Time frame: 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
Time frame: 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
Time frame: after 2 and 4 weeks after randomisation
Plan to share: No
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Fresenius Medical Care Deutschland GmbH