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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Congenital Disorders; Renal Failure
• Interventions: Other: HD, Magnetic Resonance Imaging (MRI) scans

• Registration Number: NCT03280901
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

Brief 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.

Study Timeline

• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-13
• Study Start: 2018-01-08
• Primary Completion: 2019-05-25
• Study Completion: 2020-08-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Age 18-80, male and female
• Informed consent signed and dated by study patient and investigator/authorised physician
• Average (4 weeks prior to recruitment) Ultrafiltration volumes ≥ 0.5 litres/ dialysis session
• Receiving dialysis via an arteriovenous fistula
• Must be able to follow simple instruction in English (on safety grounds for MRI scans) and be able to understand the nature and requirements of the study
• Stable dialysis prescription
• CKD5 (Chronic kidney disease) patients having renal replacement therapy with haemodialysis/ haemodiafiltration (>90 days)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard HD	HD, Magnetic Resonance Imaging (MRI) scans	HD with constant temperature of 37°C, MRI scans of the heart, kidneys and brain during HD sessions
Thermocontrolled HD	HD, Magnetic Resonance Imaging (MRI) scans	HD applying the Blood Temperature Monitor (BTM), MRI scans of the heart, kidneys and brain during HD sessions

Primary Outcome Measures

Name	Time	Method
Change in cerebral perfusion during standard HD and thermocontrolled HD	after 2 and 4 weeks after randomisation	Change in cerebral perfusion during standard HD and thermocontrolled HD using ASL
Change in cardiac output during standard HD and thermocontrolled HD	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)
Change in renal perfusion during standard HD and thermocontrolled HD	after 2 and 4 weeks after randomisation	Change in renal perfusion using Arterial Spin Labelling (ASL) and renal artery flow using PC-MRI

Trial Locations

Locations (1)

University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine; 🇬🇧 Nottingham, United Kingdom