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Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02494843
Study type Interventional
Source University of Nottingham
Contact
Status Completed
Phase N/A
Start date November 2014
Completion date December 31, 2015

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