Renal FailureHD-REMODELNCT03280901
HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life Assessed by MRI Scanning
A study testing HD, Magnetic Resonance Imaging (MRI) scans in people with Renal Failure and Cardiovascular Diseases, run by Fresenius Medical Care Deutschland GmbH at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure, Cardiovascular Diseases, Congenital Disorders
- What is being tested?
- HD, Magnetic Resonance Imaging (MRI) scans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jan 2018to 20 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine
Nottingham
About this study
Official title: 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.
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.
- Conditions
- Renal Failure, Cardiovascular Diseases, Congenital Disorders
- Being tested
- HD, Magnetic Resonance Imaging (MRI) scans
- Keywords
- renal replacement therapy, haemodialysis, haemodiafiltration
- Medical subject headings
- Renal Insufficiency, Cardiovascular Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD, Magnetic Resonance Imaging (MRI) scansOther
HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions
| Study group | Role | What they receive |
|---|---|---|
| Standard HD | Experimental | HD with constant temperature of 37°C, MRI scans of the heart, kidneys and brain during HD sessions Receives: 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 Receives: Other: HD, Magnetic Resonance Imaging (MRI) scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: after 2 and 4 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start8 Jan 2018
- Primary completion25 May 2019
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- monocentric, block randomized, open, crossover study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maarten Taal, Professor, Study chair, University of Nottingham, Division of Medical Sciences and Graduate Entry MedicineNicolas Selby, Dr, Principal investigator, University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280901
- Sponsor's protocol ID
- HD-Remodel-UK-01
- Other IDs
- IRAS 207142
- Acronym
- HD-REMODEL
- Status last verified
- Jan 2021
- First submitted
- 28 Aug 2017
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life (HD-REMODEL) Assessed by MRI Scanning
- ClinicalTrials.gov ID
- NCT03280901
- Acronym / sponsor ID
- HD-REMODEL / HD-Remodel-UK-01
- Conditions
- Renal Failure, Cardiovascular Diseases, Congenital Disorders
- Keywords
- renal replacement therapy, haemodialysis, haemodiafiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- monocentric, block randomized, open, crossover study
| Arm | Type | Receives |
|---|---|---|
| Standard HD | Experimental | Other: HD, Magnetic Resonance Imaging (MRI) scansHD with constant temperature of 37°C, MRI scans of the heart, kidneys and brain during HD sessions |
| Thermocontrolled HD | Experimental | Other: HD, Magnetic Resonance Imaging (MRI) scansHD applying the Blood Temperature Monitor (BTM), MRI scans of the heart, kidneys and brain during HD sessions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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:
- Dialysed via a synthetic line, central venous catheter or graft
- Qa < 500ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD, Magnetic Resonance Imaging (MRI) scansHD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions | Other | Standard HD, Thermocontrolled HD |
Primary outcome
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)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Renal Failure
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
RecruitingPhase 1
Renal Impairment Pharmacokinetics (PK) Trial of Afabicin
Renal Impairment
RecruitingObservational study
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Gastric Antral Vascular Ectasia, Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD, Magnetic Resonance Imaging (MRI) scans in people with Renal Failure and Cardiovascular Diseases, run by Fresenius Medical Care Deutschland GmbH at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac output during standard HD and thermocontrolled HD (time frame: after 2 and 4 weeks after randomisation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.