Skip to main content
OpenTrials
Completed

NCT Number: NCT02494843

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

online Hemodiafiltration

Other

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

Other names: Hemodiafiltration

Hemodialysis

Other

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

Other names: Haemodialysis

Primary outcomes

  1. The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF

    Time frame: 2 week

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Fresenius Medical Care Deutschland GmbH

Registry information

Acronym: CAMRID

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2015
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.