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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Renal Failure; Congenital Disorders
• Intervention / Treatment: Other: HD, Magnetic Resonance Imaging (MRI) scans

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Standard HD; 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; HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions
EXPERIMENTAL: Thermocontrolled HD; 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; HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fresenius Medical Care Deutschland GmbH
• Investigators: Study Chair: Maarten Taal, Professor, University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine; Principal Investigator: Nicolas Selby, Dr, University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 8, 2018
• Primary Completion (ACTUAL): May 25, 2019
• Study Completion (ACTUAL): August 20, 2020

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (ACTUAL): September 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: haemodialysis; renal replacement therapy; haemodiafiltration
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: HD-Remodel-UK-01; IRAS 207142 (OTHER_GRANT: Health Research Authority UK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No