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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03280901
Recruitment Status : Active, not recruiting
First Posted : September 13, 2017
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH

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.

Condition or disease Intervention/treatment Phase
Renal Failure Cardiovascular Diseases Congenital Disorders Other: HD, Magnetic Resonance Imaging (MRI) scans Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: monocentric, block randomized, open, crossover study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life (HD-REMODEL) Assessed by MRI Scanning
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in cardiac output during standard HD and thermocontrolled HD [ Time Frame: after 2 and 4 weeks after randomisation ]
    Change in cardiac output during standard HD and thermocontrolled HD using Phase Contrast Magnetic Resonance Imaging (PC-MRI)

  2. Change in renal perfusion during standard HD and thermocontrolled HD [ Time Frame: after 2 and 4 weeks after randomisation ]
    Change in renal perfusion using Arterial Spin Labelling (ASL) and renal artery flow using PC-MRI

  3. Change in cerebral perfusion during standard HD and thermocontrolled HD [ Time Frame: after 2 and 4 weeks after randomisation ]
    Change in cerebral perfusion during standard HD and thermocontrolled HD using ASL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280901


Locations
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United Kingdom
University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine
Nottingham, United Kingdom
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
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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
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Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT03280901    
Other Study ID Numbers: HD-Remodel-UK-01
IRAS 207142 ( Other Grant/Funding Number: Health Research Authority UK )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fresenius Medical Care Deutschland GmbH:
renal replacement therapy
haemodialysis
haemodiafiltration
Additional relevant MeSH terms:
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Cardiovascular Diseases