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 | Not Specified |
| 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/ |
"ROR" |
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, KFOC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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 |
