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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

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

Conditions
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Renal Failure, Cardiovascular Diseases, Congenital Disorders

Intervention / Treatment
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* Other: HD, Magnetic Resonance Imaging (MRI) scans


Participation Criteria
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Eligibility Criteria
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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: Emergency medical attention Infusion of additional fluid Loss in consciousness Arrhythmia Chest pain Or any other medical condition that precludes the scan session in opinion of the investigator 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: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: monocentric, block randomized, open, crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard HD<br>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<br>* HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions<br>|
| Experimental: Thermocontrolled HD<br>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<br>* HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal replacement therapy, haemodialysis, haemodiafiltration