Kidney FailureFREDI-CALNCT03925454
FREquent DIalysis & Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity & Quality of Life
An observational study of Kidney Failure, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Individuals with kidney failure are kept alive using dialysis machines designed to remove toxic substances and excess fluid from the blood. Standard dialysis is undertaken three times a week at a dialysis unit, supported by a team of specialist dialysis nurses (so called in-centre haemodiafiltration or ICHDF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Mar 2019to 13 Jan 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The start aims to recruit at the Wessex Kidney Centre, a regional renal and transplant centre based at Queen Alexandra Hospital, Portsmouth, UK (part of Portsmouth Hospitals NHS Trust). The patients involved in the study would have chosen their modality of dialysis in accordance with standard clinical practice and will not change any aspect of their treatment to meet the requirements of this study.
Who may be able to join
- Receiving HHD or ICHDF for more than 3 months and less than 36 months.
- Haemoglobin equal to or greater than100 g/L at enrolment.
- Willing and physically able to undertake the study assessments/tests
- Willing to provide blood for storage and future analysis
- Able to give informed consent
Who cannot join
- Living donor transplant or change to peritoneal dialysis planned
- Physical assessments contraindicated for the following clinical reasons
- Acute Coronary Syndrome (ACS) within the last 3 months (chest pain, ECG changes or typical biomarker elevation).
- Any current uncontrolled cardiac dysrhythmias causing symptoms (chest pain, palpitations, syncope or dizziness)
- Symptomatic aortic stenosis
- New York Heart Association grade IV Heart failure
Show all 13Show fewer
- Severe chronic obstructive pulmonary disease
- Acute pulmonary embolus or pulmonary infarction in the last 3 months
- Current acute myocarditis or pericarditis
- Suspected or known dissecting aneurysm
- Acute systemic infection, accompanied by fever, body aches or swollen lymph glands
- Pregnancy
- Life expectancy of less than twelve months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: FREquent DIalysis and Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity and Quality of Life: an Observational Pilot Study
Individuals with kidney failure are kept alive using dialysis machines designed to remove toxic substances and excess fluid from the blood. Standard dialysis is undertaken three times a week at a dialysis unit, supported by a team of specialist dialysis nurses (so called in-centre haemodiafiltration or ICHDF). Each session lasts approximately 4 hours, during which time the fluid and toxins which have built up since the last session of treatment are removed from the blood. The rapid removal of fluid that takes place using this technique often causes unpleasant symptoms such as cramps and dizziness, as well as a "hangover", which may last several hours. It can also cause problems with the heart in the long-term.
In recent years, individuals requiring dialysis have been able to choose between standard ICHDF or having haemodialysis at home (HHD) using a convenient table top machine called NxStage System One. This device is used more frequently than in ICHDF and for shorter sessions. As a result, the amount of fluid removed during each session is less than with ICHDF. This may be beneficial to the heart, but may also make these individuals feel generally better, which may make them want to be more physically active. It may also reduce the time taken to recover from any symptoms experienced after dialysis.
Over a 12 month period, markers of heart damage (using blood tests and scans of the heart) in patients receiving frequent HHD will be studied and the results will be compared with a group of patients receiving ICHDF. The study will also compare any symptoms they may have, how fit they are, how physically active they are and how well they sleep. In addition, the investigators will assess how well fluid balance is maintained in each group and measure the changes in their remaining kidney function during this time.
- Conditions
- Kidney Failure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| In-Centre Haemodiafiltration (ICHDF) Group | Participants undergoing ICHDF treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study. | |
| Home HaemoDialysis (HHD) Group | Participants undergoing HHD treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and post-dialysis levels of BNP
Brain Natriuretic Peptide (BNP) is one of the biomarkers of myocardial damage, it's level will be measued in EDTA anticoagulated participants' blood samples.
Measured: 12 months
Pre- and post-dialysis levels of NTpro-BNP
N-terminal pro-brain natriuretic peptide (NTpro-BNP) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples.
Measured: 12 months
Pre- and post-dialysis levels of TNT
Troponin-T (TNT) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples
Measured: 12 months
Pre- and post-dialysis levels of Tnl
Troponin-L (Tnl) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples.
Measured: 12 months
Left-ventricular mass
Left-ventricular mass is a well-established measure that can independently predict adverse cardiovascular events and will be determined using echocardiogram in this study
Measured: 12 months
Ejection fraction
Visual Ejection fraction, Biplane Ejection fraction
Measured: 12 months
Left ventricular global strain
Average GLS
Measured: 12 months
Right atrial volume
Dertermine using echocardiogram
Measured: 12 months
Integrated Back Scatter
Dertermine using echocardiogram
Measured: 12 months
Secondary outcomes (32)
Peripheral skeletal muscle oxygenation using near-infrared spectroscopy
Pulmonary gas exchange analyser generated data file
Measured: 12 months
Maximal cardiopulmonary exercise testing (CPET)
Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function
Measured: 12 months
Breath-by-breath changes in pulmonary gas exchange and ventilation
Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function
Measured: 12 months
Objective assessment of habitual physical activity using a triaxial
Triaxial accelerometer generated data file consist of time went to sleep and time of waking up
Measured: 12 months
Objective assessment of habitual physical activity using a triaxial accelerometer with a validated sleep diary
Triaxial accelerometer generated data file consist of time went to sleep and time of waking up
Measured: 12 months
Blood pressure measued using NICOM sensor
Non-invasive haemodynamic measurements using NICOM sensor for blood pressure
Measured: 12 months
Cardiac index measued using NICOM sensor
Non-invasive haemodynamic measurements using NICOM sensor for cardiac index
Measured: 12 months
Stroke volume measued using NICOM sensor
Non-invasive haemodynamic measurements using NICOM sensor for stroke volume
Measured: 12 months
Cardiac output measued using NICOM sensor
Non-invasive haemodynamic measurements using NICOM sensor for cardiac output
Measured: 12 months
Total peripheral resistance measued using NICOM sensor
Non-invasive haemodynamic measurements using NICOM sensor for total peripheral resistance
Measured: 12 months
Cardiac power index measued using NICOM sensor
Non-invasive haemodynamic measurements using NICOM sensor for cardiac power index
Measured: 12 months
Concentration of pre and post dialysis Beta-2-microglobulin
Markers of inflammation and dialysis adequacy
Measured: 12 months
Cncentration of pre-dialysis FGF-23
Markers of inflammation and dialysis adequacy
Measured: 12 months
Cncentration of pre-dialysis High-sensitivity CRP
Markers of inflammation and dialysis adequacy
Measured: 12 months
Cncentration of pre-dialysis Interleukin-6
Markers of inflammation and dialysis adequacy
Measured: 12 months
Cncentration of pre-dialysis Interleukin-10
Markers of inflammation and dialysis adequacy
Measured: 12 months
Urine creatinine level
Residual renal function
Measured: 12 months
Urine urea level
Residual renal function
Measured: 12 months
RAPA score
Derivered from RAPA questionnaire
Measured: 12 months
KDQoL-36 score
Derivered from KDQoL-36 questionnaire
Measured: 12 months
FACIT-F score
Derivered from FACIT-F questionnaire
Measured: 12 months
Recovery time
Patient reported recovery time after dialysis sessions and length of sleep after last dialysis session
Measured: 12 months
Lean tissue mass
Hydration status through body composition monitoring
Measured: 12 months
fat mass
Hydration status through body composition monitoring
Measured: 12 months
Extra/intracellular water
Hydration status through body composition monitoring
Measured: 12 months
Total body water
Hydration status through body composition monitoring
Measured: 12 months
Saliva flow rate
Part of hydration status determiantion
Measured: 12 months
Change in number of antihypertensive agents
Number of antihypertensive agents
Measured: Over 12 months period
Change in erythropoietin dosage
Erythropoietin dosage
Measured: Over 12 months period
Number of in-patient days with cause
Date of hospital admission and date of hospital discharge
Measured: Over 12 months period
Major adverse cardiovascular events (MACE)
Number of events considered a Major Adverse Cardiovascular Event
Measured: Over 12 months period
All-cause and cardiovascular mortality
Number of withdrawal Information: Death of patient
Measured: Over 12 months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start19 Mar 2019
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- NxStage Medical, University of Portsmouth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925454
- Sponsor's protocol ID
- PHT/2017/122
- Acronym
- FREDI-CAL
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2019
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be stored anonymously once entered onto the case report form and data management database. The database will be utilised to safely and securely handle all study data and to minimise any potential risks associated with data collection. Any identifiable data, such as participant medical notes, will be kept confidential in accordance with the Caldicott Principles.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FREquent DIalysis and Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity and Quality of Life: an Observational Pilot Study
- ClinicalTrials.gov ID
- NCT03925454
- Acronym / sponsor ID
- FREDI-CAL / PHT/2017/122
- Conditions
- Kidney Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- NxStage Medical, University of Portsmouth
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 24 Apr 2019 (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.
Individuals with kidney failure are kept alive using dialysis machines designed to remove toxic substances and excess fluid from the blood. Standard dialysis is undertaken three times a week at a dialysis unit, supported by a team of specialist dialysis nurses (so called in-centre haemodiafiltration or ICHDF). Each session lasts approximately 4 hours, during which time the fluid and toxins which have built up since the last session of treatment are removed from the blood. The rapid removal of fluid that takes place using this technique often causes unpleasant symptoms such as cramps and dizziness, as well as a "hangover", which may last several hours. It can also cause problems with the heart in the long-term.
In recent years, individuals requiring dialysis have been able to choose between standard ICHDF or having haemodialysis at home (HHD) using a convenient table top machine called NxStage System One. This device is used more frequently than in ICHDF and for shorter sessions. As a result, the amount of fluid removed during each session is less than with ICHDF. This may be beneficial to the heart, but may also make these individuals feel generally better, which may make them want to be more physically active. It may also reduce the time taken to recover from any symptoms experienced after dialysis.
Over a 12 month period, markers of heart damage (using blood tests and scans of the heart) in patients receiving frequent HHD will be studied and the results will be compared with a group of patients receiving ICHDF. The study will also compare any symptoms they may have, how fit they are, how physically active they are and how well they sleep. In addition, the investigators will assess how well fluid balance is maintained in each group and measure the changes in their remaining kidney function during this time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Centre Haemodiafiltration (ICHDF) Group | – | –Participants undergoing ICHDF treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study. |
| Home HaemoDialysis (HHD) Group | – | –Participants undergoing HHD treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The start aims to recruit at the Wessex Kidney Centre, a regional renal and transplant centre based at Queen Alexandra Hospital, Portsmouth, UK (part of Portsmouth Hospitals NHS Trust). The patients involved in the study would have chosen their modality of dialysis in accordance with standard clinical practice and will not change any aspect of their treatment to meet the requirements of this study.
Key inclusion criteria (5 listed)
- Receiving HHD or ICHDF for more than 3 months and less than 36 months.
- Haemoglobin equal to or greater than100 g/L at enrolment.
- Willing and physically able to undertake the study assessments/tests
- Willing to provide blood for storage and future analysis
- Able to give informed consent
Key exclusion criteria (13 listed)
- Living donor transplant or change to peritoneal dialysis planned
- Physical assessments contraindicated for the following clinical reasons
- Pregnancy
- Life expectancy of less than twelve months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre- and post-dialysis levels of BNP
Time frame: 12 months
Brain Natriuretic Peptide (BNP) is one of the biomarkers of myocardial damage, it's level will be measued in EDTA anticoagulated participants' blood samples.
Pre- and post-dialysis levels of NTpro-BNP
Time frame: 12 months
N-terminal pro-brain natriuretic peptide (NTpro-BNP) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples.
Pre- and post-dialysis levels of TNT
Time frame: 12 months
Troponin-T (TNT) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples
Pre- and post-dialysis levels of Tnl
Time frame: 12 months
Troponin-L (Tnl) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples.
Left-ventricular mass
Time frame: 12 months
Left-ventricular mass is a well-established measure that can independently predict adverse cardiovascular events and will be determined using echocardiogram in this study
Ejection fraction
Time frame: 12 months
Visual Ejection fraction, Biplane Ejection fraction
Left ventricular global strain
Time frame: 12 months
Average GLS
Right atrial volume
Time frame: 12 months
Dertermine using echocardiogram
Integrated Back Scatter
Time frame: 12 months
Dertermine using echocardiogram
32 secondary outcomes
Peripheral skeletal muscle oxygenation using near-infrared spectroscopy
Time frame: 12 months
Maximal cardiopulmonary exercise testing (CPET)
Time frame: 12 months
Breath-by-breath changes in pulmonary gas exchange and ventilation
Time frame: 12 months
Objective assessment of habitual physical activity using a triaxial
Time frame: 12 months
Objective assessment of habitual physical activity using a triaxial accelerometer with a validated sleep diary
Time frame: 12 months
Blood pressure measued using NICOM sensor
Time frame: 12 months
Cardiac index measued using NICOM sensor
Time frame: 12 months
Stroke volume measued using NICOM sensor
Time frame: 12 months
Cardiac output measued using NICOM sensor
Time frame: 12 months
Total peripheral resistance measued using NICOM sensor
Time frame: 12 months
Cardiac power index measued using NICOM sensor
Time frame: 12 months
Concentration of pre and post dialysis Beta-2-microglobulin
Time frame: 12 months
Cncentration of pre-dialysis FGF-23
Time frame: 12 months
Cncentration of pre-dialysis High-sensitivity CRP
Time frame: 12 months
Cncentration of pre-dialysis Interleukin-6
Time frame: 12 months
Cncentration of pre-dialysis Interleukin-10
Time frame: 12 months
Urine creatinine level
Time frame: 12 months
Urine urea level
Time frame: 12 months
RAPA score
Time frame: 12 months
KDQoL-36 score
Time frame: 12 months
FACIT-F score
Time frame: 12 months
Recovery time
Time frame: 12 months
Lean tissue mass
Time frame: 12 months
fat mass
Time frame: 12 months
Extra/intracellular water
Time frame: 12 months
Total body water
Time frame: 12 months
Saliva flow rate
Time frame: 12 months
Change in number of antihypertensive agents
Time frame: Over 12 months period
Change in erythropoietin dosage
Time frame: Over 12 months period
Number of in-patient days with cause
Time frame: Over 12 months period
Major adverse cardiovascular events (MACE)
Time frame: Over 12 months period
All-cause and cardiovascular mortality
Time frame: Over 12 months period
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 7 Apr 2023.
- Individual participant dataSharing planned: No. All data will be stored anonymously once entered onto the case report form and data management database. The database will be utilised to safely and securely handle all study data and to minimise any potential risks associated with data collection. Any identifiable data, such as participant medical notes, will be kept confidential in accordance with the Caldicott Principles.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, run by Portsmouth Hospitals NHS Trust 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 5 inclusion and 13 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 7 Apr 2023. 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?
Pre- and post-dialysis levels of BNP (time frame: 12 months). The study lists 9 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 7 Apr 2023.