University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine
Nottingham, United Kingdom
NCT Number: NCT03280901
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Nottingham, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Exclusion criteria
Inclusion criteria
HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions
Time frame: after 2 and 4 weeks after randomisation
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 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 using ASL
Fresenius Medical Care Deutschland GmbH
Industry
HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life (HD-REMODEL) Assessed by MRI Scanning
Acronym: HD-REMODEL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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