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
Scientific
Foothills Medical Center
1403 -29th St NW
Calgary
T2N 2T9
Canada
| Phone | +1 403 944 2595 |
|---|---|
| Braden.Manns@calgaryhealthregion.ca |
Study information
| Study design | Randomised, controlled, cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | '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 study start date | 01/07/2001 |
| Completion date | 01/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
T2N 2T9
Canada
Sponsor information
Kidney Foundation of Canada (Canada)
Research organisation
Research organisation
300-5165 Sherbrooke Street West
Montreal
H4A 1T6
Canada
| Phone | +1 514 369 4806 |
|---|---|
| webmaster@kidney.ca | |
| Website | http://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 | 19/07/2009 | 05/08/2021 | Yes | No |
Editorial Notes
05/08/2021: Publication reference and total final enrolment added.
