Contact information
Type
Scientific
Primary contact
Dr Braden Manns
ORCID ID
Contact details
Foothills Medical Center
1403 -29th St NW
Calgary
T2N 2T9
Canada
+1 403 944 2595
Braden.Manns@calgaryhealthregion.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15603
Study information
Scientific title
Acronym
Study hypothesis
Health related quality of life for patients treated with a strategy to increase dialysis adequacy will be similar to health related quality of life when treated with standard dialysis.
Ethics approval
Ethics approval received from the Conjoint Medical Ethics Board of the University of Calgary on the 7th December 2000 (ref: 15603).
Study design
Randomised, controlled, cross-over study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Kidney failure/haemodialysis
Intervention
All patients were treated for 4 weeks with "4 hours of haemodialysis" three times per week for one month (the run-in period). Then all patients were randomised to receive each of the four noted treatments (below), for six weeks each, in a random order. There was no wash out period between each of the four treatment periods. The intention was that all patients would receive each of the four treatments. Total study time was 24 weeks, plus the 4 week run-in.
1. Standard haemodialysis: four hours of haemodialysis three times per week - haemodialysis was undertaken using a high flux, high efficiency polysulfone dialyser (i.e., F80A dialyser [Fresenius, Inc, Walnut Creek, CA] or equivalent), with a blood flow of 350 - 400 ml/min and a dialysate flow of 500 ml/min
2. Increased dialysate flow: patients received standard dialysis for four hours three times per week but the dialysate flow rate was 800 ml/min rather than 500 ml/min
3. Increased dialysis time: haemodialysis for 4.5 hours, three times per week
4. Double dialyser: patients received haemodialysis for four hours three times per week with two F80A dialysers connected by a Y-connector in a parallel configuration during each run using the method described by Powers et al. Dialysate flow was 800 ml/min
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
'End-Stage Renal Disease (ESRD) symptoms' domain of the Kidney Disease Quality of Life Short Form (KDQOL-SF) measured at the end of each 6-week treatment session.
Secondary outcome measures
1. Health Utility Index mark 2 (HUI 2) utility score, evaluated during the last week of the treatment (i.e. during week 6 of each treatment period)
2. Exploratory measures of Health-Related Quality Of Life (HRQOL): other domains of the Kidney Disease Quality of Life (KDQOL) and 36-item Short Form health survey (SF-36), evaluated during the last week of the treatment (i.e. during week 6 of each treatment period)
Overall trial start date
01/07/2001
Overall trial end date
01/07/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients on a stable regimen of haemodialysis greater than or equal to 3 months
2. Dry weight greater than or equal to 80 kg
3. Kt/V less than 1.2 on two occasions in the previous 6 months or requirement for greater than 12 hours of haemodialysis per week because of a history of inadequate dialysis
4. Blood flow rate greater than 350 ml/min through a well functioning access
5. Aged greater than 18, both sexes
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
18
Participant exclusion criteria
1. Scheduled renal transplant in the next 6 months
2. Contraindication to intradialytic anticoagulation
3. Requirement for greater than 4.5 hours of haemodialysis three times per week for the purpose of volume removal due to excessive interdialytic weight gains or intradialytic hypotension/cramping
4. Failure to provide informed consent
Recruitment start date
01/07/2001
Recruitment end date
01/07/2004
Locations
Countries of recruitment
Canada
Trial participating centre
Foothills Medical Center
Calgary
T2N 2T9
Canada
Sponsor information
Organisation
Kidney Foundation of Canada (Canada)
Sponsor details
300-5165 Sherbrooke Street West
Montreal
H4A 1T6
Canada
+1 514 369 4806
webmaster@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