Contact information
Type
Scientific
Primary contact
Dr Bruce Culleton
ORCID ID
Contact details
Foothills Hospital
1403-29th ST NW
Calgary
T2N 2T9
Canada
+1 403 944 8166
bruce.culleton@calgaryhealthregion.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Nocturnal haemodialysis and conventional three times per week haemodialysis will not differ with respect to progression of LV mass (measured using Cardiac Magnetic Resonance [CMR]) at 6 months.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
End-stage kidney disease
Intervention
Subjects are randomised to nocturnal haemodialysis or conventional three times per week haemodialysis (controls).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Change in left ventricular mass (measured by CMR) at 6 months.
Secondary outcome measures
1. Mean change in systolic Blood Pressure (BP)
2. Change in HRQOL (Health-Related Quality-Of-Life)
3. Mean change in Haematocrit (Hct)/Erythropoietin (Epo) ratio
4. Mean change in calcium - phosphorus product
Overall trial start date
01/08/2004
Overall trial end date
30/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
All adult haemodialysis patients in Alberta, Canada are eligible.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
38 subjects
Participant exclusion criteria
Patients who are unable to perform NHD due to physical or mental incapacity.
Recruitment start date
01/08/2004
Recruitment end date
30/06/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Foothills Hospital
Calgary
T2N 2T9
Canada
Sponsor information
Organisation
Kidney Foundation of Canada (Canada)
Sponsor details
300-5165 Sherbrooke ST W
Montreal
Quebec
H4A 1T6
Canada
research@kidney.ca
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Kidney Foundation of Canada (Canada)
Alternative name(s)
La Fondation canadienne du rein, KFOC
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Canada
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
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17878421
Publication citations
-
Results
Culleton BF, Walsh M, Klarenbach SW, Mortis G, Scott-Douglas N, Quinn RR, Tonelli M, Donnelly S, Friedrich MG, Kumar A, Mahallati H, Hemmelgarn BR, Manns BJ, Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life: a randomized controlled trial., JAMA, 2007, 298, 11, 1291-1299, doi: 10.1001/jama.298.11.1291.