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

NCT ID: NCT03280901

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2020-08-20

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.

Conditions

Renal Failure; Cardiovascular Diseases; Congenital Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard HD

HD with constant temperature of 37°C, MRI scans of the heart, kidneys and brain during HD sessions

Group Type: EXPERIMENTAL

HD, Magnetic Resonance Imaging (MRI) scans

Intervention Type: OTHER

HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions

Thermocontrolled HD

HD applying the Blood Temperature Monitor (BTM), MRI scans of the heart, kidneys and brain during HD sessions

Group Type: EXPERIMENTAL

HD, Magnetic Resonance Imaging (MRI) scans

Intervention Type: OTHER

HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maarten Taal, Professor

Role: STUDY_CHAIR

University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine

Nicolas Selby, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine

Locations

University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

IRAS 207142

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HD-Remodel-UK-01

Identifier Type: -

Identifier Source: org_study_id