Other Postprocedural Cardiac Functional DisturbancesCAMRIDNCT02494843
Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID)
A study testing online Hemodiafiltration and Hemodialysis in people with Other Postprocedural Cardiac Functional Disturbances and Myocardial Perfusion, run by University of Nottingham.
Trial summary
The purpose of this study is to characterise, in detail, the cardiac structure, function and perfusion of those on haemodialysis and haemodiafiltration, comparing the two modalities to ascertain if haemodiafiltration provides relative myocardial protection compared to conventional haemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Other Postprocedural Cardiac Functional Disturbances, Myocardial Perfusion
- What is being tested?
- online Hemodiafiltration and Hemodialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to 31 Dec 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Able to give informed consent
- CKD5 on chronic haemodialysis
- Receiving dialysis via an arteriovenous fistula
- Must be able to follow simple instruction in English (on safety grounds for MRI scans)
Who cannot join
- Change in ideal dry weight in 4 weeks prior to recruitment
- Instability on dialysis in 4 weeks prior to recruitment leading to either:
- Emergency medical attention
- Infusion of additional fluid
- Loss in consciousness
- Arrhythmia
Show all 14Show fewer
- Chest pain
- Dialysed via a synthetic line or graft
- Qa < 500ml/min
- NYHA Stage IV heart failure
- Active infection or malignancy
- Contraindication to MRI scanning including claustrophobia
- Mental incapacity to consent
- Pregnancy or planning pregnancy
About this study
The purpose of this study is to characterise, in detail, the cardiac structure, function and perfusion of those on haemodialysis and haemodiafiltration, comparing the two modalities to ascertain if haemodiafiltration provides relative myocardial protection compared to conventional haemodialysis.
Read the detailed description
Trial Configuration: Non-blinded crossover pilot study Setting: Secondary care Sample size estimate: This is a pilot study therefore power calculations are not appropriate. A group size of 12 participants has been selected for feasibility.
Number of participants: 12 patients to complete study Description of interventions
- 6 sessions of conventional haemodialysis each lasting 4 hours
- 6 sessions of online haemodiafiltration each lasting 4 hours
- 2 sessions of Cardiac MRI each lasting 6 hours in total to take place around 6th session of dialysis Randomisation and blinding: This is an open study. Statistical methods: All continuous variables will be tested for normality. The primary and continuous secondary endpoints will be compared between the two modalities using a paired t test or Wilcoxon signed rank test as appropriate. The association between categorical variables will be tested using the Chi squared or Fischer's Exact test. An alpha error at 0.05 will be judged as significant.
- Being tested
- online Hemodiafiltration, Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online HemodiafiltrationOther
Also called Hemodiafiltration
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
HemodialysisOther
Also called Haemodialysis
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
| Study group | Role | What they receive |
|---|---|---|
| Online haemodiafiltration | Active comparator | Not described Receives: Other: online Hemodiafiltration; Other: Hemodialysis |
| Haemodialysis | Active comparator | Not described Receives: Other: online Hemodiafiltration; Other: Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF
Measured: 2 week
Secondary outcomes (4)
The change in segmental cardiac perfusion during conventional HD and HDF
Measured: 2 week
The change in global and segmental cardiac function as measured by phase-contrast MRI
Measured: 2 week
Serum markers of cardiac damage, renal, liver function, clotting, full blood count
Bloods collected at the end of 2 week study period on the scan days on HD and HDF
Measured: 2 weeks
Reported tolerability of cardiac MRI scanning whilst having dialysis
On 2 MRI study days
Measured: On 2 MRI study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Postprocedural Cardiac Functional DisturbancesStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care Deutschland GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494843
- Sponsor's protocol ID
- 14025
- Acronym
- CAMRID
- Status last verified
- Apr 2020
- First submitted
- 7 Jul 2015
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID)
- ClinicalTrials.gov ID
- NCT02494843
- Acronym / sponsor ID
- CAMRID / 14025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Fresenius Medical Care Deutschland GmbH
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 10 Jul 2015 (estimated)
- 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, the cardiac structure, function and perfusion of those on haemodialysis and haemodiafiltration, comparing the two modalities to ascertain if haemodiafiltration provides relative myocardial protection compared to conventional haemodialysis.
Detailed description
Trial Configuration: Non-blinded crossover pilot study Setting: Secondary care Sample size estimate: This is a pilot study therefore power calculations are not appropriate. A group size of 12 participants has been selected for feasibility.
Number of participants: 12 patients to complete study Description of interventions
- 6 sessions of conventional haemodialysis each lasting 4 hours
- 6 sessions of online haemodiafiltration each lasting 4 hours
- 2 sessions of Cardiac MRI each lasting 6 hours in total to take place around 6th session of dialysis Randomisation and blinding: This is an open study. Statistical methods: All continuous variables will be tested for normality. The primary and continuous secondary endpoints will be compared between the two modalities using a paired t test or Wilcoxon signed rank test as appropriate. The association between categorical variables will be tested using the Chi squared or Fischer's Exact test. An alpha error at 0.05 will be judged as significant.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online haemodiafiltration | Active comparator | Other: online Hemodiafiltration, Other: Hemodialysis |
| Haemodialysis | Active comparator | Other: online Hemodiafiltration, Other: Hemodialysis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years
- Able to give informed consent
- CKD5 on chronic haemodialysis
- Receiving dialysis via an arteriovenous fistula
- Must be able to follow simple instruction in English (on safety grounds for MRI scans)
Key exclusion criteria (14 listed)
- Change in ideal dry weight in 4 weeks prior to recruitment
- Instability on dialysis in 4 weeks prior to recruitment leading to either:
- Dialysed via a synthetic line or graft
- Qa < 500ml/min
- NYHA Stage IV heart failure
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 |
|---|---|---|
| online HemodiafiltrationAlso: HemodiafiltrationEffects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis. | Other | Haemodialysis, Online haemodiafiltration |
| HemodialysisAlso: HaemodialysisEffects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis. | Other | Haemodialysis, Online haemodiafiltration |
Primary outcome
The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF
Time frame: 2 week
4 secondary outcomes
The change in segmental cardiac perfusion during conventional HD and HDF
Time frame: 2 week
The change in global and segmental cardiac function as measured by phase-contrast MRI
Time frame: 2 week
Serum markers of cardiac damage, renal, liver function, clotting, full blood count
Time frame: 2 weeks
Reported tolerability of cardiac MRI scanning whilst having dialysis
Time frame: On 2 MRI study days
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 30 Apr 2020.
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.
Questions about this trial
What is this clinical trial studying?
A study testing online Hemodiafiltration and Hemodialysis in people with Other Postprocedural Cardiac Functional Disturbances and Myocardial Perfusion, run by University of Nottingham.
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 14 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 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF (time frame: 2 week). 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 30 Apr 2020.