Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077122814
Study information
Scientific title
Acronym
Study hypothesis
1. Haemodialysis with ultrafiltration is capable of inducing myocardial stunning in individuals both with and without coronary artery disease
2. Myocardial stunning induced by haemodialysis may be ameliorated by the use of biofeedback-controlled haemodialysis, despite identical total ultrafiltration
Ethics approval
Not provided at time of registration
Study design
Randomised crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Urological and Genital Diseases: Haemodialysis
Intervention
We propose to study chronic haemodialysis patients in a randomised crossover study.
The first group will undergo an initial period of standard haemodialysis followed by a period of biofeedback-controlled haemodialysis.
The second group will do the same in reverse.
At the end of both periods, all patients will undergo echocardiography performed at regular intervals throughout a single haemodialysis session, and for a short period afterwards. They will also have Troponin T measured before and after the same dialysis session.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Number of regional wall abnormalities/patient
2. Ejection and shortening fractions
Secondary outcome measures
Not provided at time of registration
Overall trial start date
21/02/2003
Overall trial end date
01/04/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Patients on chronic haemodialysis
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
21/02/2003
Recruitment end date
01/04/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Southern Derbyshire Acute Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary