Myocardial Perfusion, Other Postprocedural Cardiac Functional Disturbances
Conditions
Brief 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.
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.
Interventions
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
OTHERHemodialysis
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
Sponsors
Fresenius Medical Care Deutschland GmbH
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF | 2 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in segmental cardiac perfusion during conventional HD and HDF | 2 week | — |
| The change in global and segmental cardiac function as measured by phase-contrast MRI | 2 week | — |
| Serum markers of cardiac damage, renal, liver function, clotting, full blood count | 2 weeks | Bloods collected at the end of 2 week study period on the scan days on HD and HDF |
| Reported tolerability of cardiac MRI scanning whilst having dialysis | On 2 MRI study days | On 2 MRI study days |
Outcome results
None listed