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CompletedNCT03280901HD-REMODELUpdated Jan 15, 2021

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

An interventional study of HD, Magnetic Resonance Imaging (MRI) scans in Renal Failure, Cardiovascular Diseases and Congenital Disorders, sponsored by Fresenius Medical Care Deutschland GmbH. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-15.

Sponsored by Fresenius Medical Care Deutschland GmbH · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Failure
  • Cardiovascular Diseases
  • Congenital Disorders

Keywords

  • renal replacement therapy
  • haemodialysis
  • haemodiafiltration
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherHD, Magnetic Resonance Imaging (MRI) scans

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

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: after 2 and 4 weeks after randomisation

  2. 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

    Time frame: after 2 and 4 weeks after randomisation

  3. Change in cerebral perfusion during standard HD and thermocontrolled HD

    Change in cerebral perfusion during standard HD and thermocontrolled HD using ASL

    Time frame: after 2 and 4 weeks after randomisation

06

Study locations

1 site
  • University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine
    Nottingham, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03280901
Lead sponsor
Fresenius Medical Care Deutschland GmbH
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Jan 8, 2018
Primary completion
May 25, 2019
Completion
Aug 20, 2020
Last update
Jan 15, 2021

Study contacts

Maarten Taal, Professor
study chair · University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine
Nicolas Selby, Dr
principal investigator · University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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