An evaluation of improving dialysis adequacy in large haemodialysis patients: the double dialyser study

ISRCTN	ISRCTN92573528
DOI	https://doi.org/10.1186/ISRCTN92573528
Protocol serial number	15603
Sponsor	Kidney Foundation of Canada (Canada)
Funder	Kidney Foundation of Canada (Canada)

Submission date: 19/09/2007
Registration date: 27/09/2007
Last edited: 05/08/2021

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 Braden Manns
Scientific

Foothills Medical Center
1403 -29th St NW
Calgary
T2N 2T9
Canada

Phone	+1 403 944 2595
Email	Braden.Manns@calgaryhealthregion.ca

Study information

Primary study design	Interventional
Study design	Randomised, controlled, cross-over study
Secondary study design	Randomised controlled trial
Scientific title	An evaluation of improving dialysis adequacy in large haemodialysis patients: the double dialyser study
Study objectives	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(s)	Ethics approval received from the Conjoint Medical Ethics Board of the University of Calgary on the 7th December 2000 (ref: 15603).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	'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.
Key secondary outcome measure(s)	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)
Completion date	01/07/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	18
Total final enrolment	18
Key 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
Key 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
Date of first enrolment	01/07/2001
Date of final enrolment	01/07/2004

Locations

Countries of recruitment

Canada

Study participating centre

Foothills Medical Center

Calgary
T2N 2T9
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		19/07/2009	05/08/2021	Yes	No

Editorial Notes

05/08/2021: Publication reference and total final enrolment added.