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Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID) (CAMRID)

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ClinicalTrials.gov Identifier: NCT02494843
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : July 10, 2015
Sponsor:
Collaborator:
Fresenius Medical Care Deutschland GmbH
Information provided by (Responsible Party):
University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Other Postprocedural Cardiac Functional Disturbances Myocardial Perfusion Other: online Hemodiafiltration Other: Hemodialysis Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID)
Study Start Date : November 2014
Actual Primary Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: Online haemodiafiltration Other: online Hemodiafiltration
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
Other Name: Hemodiafiltration

Other: Hemodialysis
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
Other Name: Haemodialysis

Active Comparator: Haemodialysis Other: online Hemodiafiltration
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
Other Name: Hemodiafiltration

Other: Hemodialysis
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
Other Name: Haemodialysis




Primary Outcome Measures :
  1. The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF [ Time Frame: 2 week ]

Secondary Outcome Measures :
  1. The change in segmental cardiac perfusion during conventional HD and HDF [ Time Frame: 2 week ]
  2. The change in global and segmental cardiac function as measured by phase-contrast MRI [ Time Frame: 2 week ]
  3. Serum markers of cardiac damage, renal, liver function, clotting, full blood count [ Time Frame: 2 weeks ]
    Bloods collected at the end of 2 week study period on the scan days on HD and HDF

  4. Reported tolerability of cardiac MRI scanning whilst having dialysis [ Time Frame: On 2 MRI study days ]
    On 2 MRI study days



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02494843     History of Changes
Other Study ID Numbers: 14025
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: July 10, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Pathologic Processes