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
Protocol serial number N/A
Sponsor Kidney Foundation of Canada (Canada)
Funder Kidney Foundation of Canada (Canada)
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

Foothills Hospital
1403-29th ST NW
Calgary
T2N 2T9
Canada

Phone +1 403 944 8166
Email bruce.culleton@calgaryhealthregion.ca

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesNocturnal 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) studiedEnd-stage kidney disease
InterventionSubjects are randomised to nocturnal haemodialysis or conventional three times per week haemodialysis (controls).
Intervention typeOther
Primary outcome measure(s)

Change in left ventricular mass (measured by CMR) at 6 months.

Key secondary outcome measure(s)

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

Completion date30/06/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
Sex
Target sample size at registration38
Key inclusion criteriaAll adult haemodialysis patients in Alberta, Canada are eligible.
Key exclusion criteriaPatients who are unable to perform NHD due to physical or mental incapacity.
Date of first enrolment01/08/2004
Date of final enrolment30/06/2006

Locations

Countries of recruitment

  • Canada

Study participating centre

Foothills Hospital
Calgary
T2N 2T9
Canada

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 19/09/2007 Yes No