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

ISRCTN ISRCTN92573528
DOI https://doi.org/10.1186/ISRCTN92573528
Secondary identifying numbers 15603
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

Study designRandomised, controlled, cross-over study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAn evaluation of improving dialysis adequacy in large haemodialysis patients: the double dialyser study
Study objectivesHealth 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) studiedKidney failure/haemodialysis
InterventionAll 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 typeOther
Primary outcome measure'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 measures1. 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 study start date01/07/2001
Completion date01/07/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants18
Total final enrolment18
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2001
Date of final enrolment01/07/2004

Locations

Countries of recruitment

  • Canada

Study participating centre

Foothills Medical Center
Calgary
T2N 2T9
Canada

Sponsor information

Kidney Foundation of Canada (Canada)
Research organisation

300-5165 Sherbrooke Street West
Montreal
H4A 1T6
Canada

Phone +1 514 369 4806
Email webmaster@kidney.ca
Website http://kidney.ca
ROR logo "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)
Alternative name(s)
La Fondation canadienne du rein, KFOC
Location
Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
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.