NCT03280901

HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life Assessed by MRI Scanning

HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life (HD-REMODEL) Assessed by MRI Scanning

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Renal Failure
• Cardiovascular Diseases
• Congenital Disorders

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-08
• Primary completion: 2019-05-25
• Completion: 2020-08-20
• First posted: 2017-09-13
• Last updated: 2021-01-15

Locations

1 site across 1 country: United Kingdom