Condition category
Urological and Genital Diseases
Date applied
19/09/2007
Date assigned
27/09/2007
Last edited
27/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://kidney.ca

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

Publication citations

Additional files

Editorial Notes