The effects of Nocturnal Haemodialysis (NHD) compared to conventional haemodialysis on progression of Left Ventricular (LV) mass: a randomised controlled pilot study
| ISRCTN | ISRCTN25858715 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25858715 | 
| Secondary identifying numbers | N/A | 
- Submission date
 - 08/09/2004
 - Registration date
 - 19/10/2004
 - Last edited
 - 20/09/2007
 
- Recruitment status
 - No longer recruiting
 - Overall study status
 - Completed
 - Condition category
 - Urological and Genital Diseases
 
            
            Prospectively registered
        
    
                    
                        
    
        
            
            Protocol
        
    
                    
                        
    
        
            
            Statistical analysis plan
        
    
                    
                        
    
        
            
            Results
        
    
                    
                        
    
        
            
            Individual participant data
        
    
                    
                        
    
                    
                    Plain English summary of protocol
Not provided at time of registration
Contact information
                                            Dr Bruce Culleton
Scientific
                                        Scientific
                                                Foothills Hospital
1403-29th ST NW
Calgary
T2N 2T9
Canada
                                                
| Phone | +1 403 944 8166 | 
|---|---|
| bruce.culleton@calgaryhealthregion.ca | 
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Hospital | 
| Study type | Treatment | 
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration. | 
| Health condition(s) or problem(s) studied | End-stage kidney disease | 
| Intervention | Subjects are randomised to nocturnal haemodialysis or conventional three times per week haemodialysis (controls). | 
| Intervention type | Other | 
| Primary outcome measure | 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 study start date | 01/08/2004 | 
| Completion date | 30/06/2006 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Not Specified | 
| Sex | |
| Target number of participants | 38 subjects | 
| Key inclusion criteria | All adult haemodialysis patients in Alberta, Canada are eligible. | 
| Key exclusion criteria | Patients who are unable to perform NHD due to physical or mental incapacity. | 
| Date of first enrolment | 01/08/2004 | 
| Date of final enrolment | 30/06/2006 | 
Locations
Countries of recruitment
- Canada
 
Study participating centre
                                            Foothills Hospital
                                        
                                        
                                            
                                            Calgary
T2N 2T9
Canada
                                    T2N 2T9
Canada
Sponsor information
                                            Kidney Foundation of Canada (Canada) 
Research organisation
                                        Research organisation
                                                300-5165 Sherbrooke ST W
Montreal, Quebec
H4A 1T6
Canada
                                                
| research@kidney.ca | |
| Website | http://www.kidney.ca/ | 
| https://ror.org/019a0gk53 | 
Funders
Funder type
Research organisation
                                                Kidney Foundation of Canada (Canada)
                                                
Private sector organisation / Trusts, charities, foundations (both public and private)
                                            Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
 - La Fondation canadienne du rein, The Kidney Foundation of Canada, Kidney Foundation, kidneycanada, KFOC
 - Location
 - Canada
 
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No | 
| IPD sharing plan summary | |
| Publication and dissemination plan | Not provided at time of registration | 
| IPD sharing plan | 
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? | 
|---|---|---|---|---|---|
| Results article | Results | 19/09/2007 | Yes | No |