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

NCT03280901 | Completed

• 2 other identifiers: HD-Remodel-UK-01IRAS 207142
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure; Cardiovascular Diseases; Congenital Disorders

Keywords

renal replacement therapy; haemodialysis; haemodiafiltration

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Standard HD

EXPERIMENTAL

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

Thermocontrolled HD

EXPERIMENTAL

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

Interventions

HD, Magnetic Resonance Imaging (MRI) scans OTHER

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

Standard HD; Thermocontrolled HD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (1)

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

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency; Cardiovascular Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Maarten Taal, Professor

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

  STUDY CHAIR

• Nicolas Selby, Dr

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: monocentric, block randomized, open, crossover study

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 13, 2017
• Study Start: January 8, 2018
• Primary Completion: May 25, 2019
• Study Completion: August 20, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)