Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077114320
Study information
Scientific title
Study into achievement of isonatric haemodialysis by individual tailoring of dialysate sodium according to ionic mass balance derived from online conductance monitoring
Acronym
Study hypothesis
Whether or not individualising dialysate sodium has beneficial effects on haemodialysis patients interdialytic weight gains, blood pressure and thirst when compared to standard dialysate sodium.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Urological and Genital Diseases: Renal dialysis
Intervention
The two groups will both undergo a 1-week period of initial data collection while being maintained on routine dialysis. Dialysis will be performed using a default dialysate sodium of 140 mmol/l.
The first group will then continue to dialyse against a standard dialysate sodium concentration of 140 mmol/l, while the second group undergoes a period of 1 month of sequential reduction of dialysate sodium according to online conductivity monitoring, aiming for isonatric dialysis (i.e. Ionic mass balance of 0-100 mmol of sodium). This will then be maintained for a period of one month.
After that time, there will be a crossover period of adjustment, during which the first group will have their dialysate sodium tailored to their requirements, and the second group will revert in a gradual manner to a dialysate sodium of 140 mmol/l.
Again the two groups will be maintained for a further month, before both groups revert to a standard dialysate sodium at the end of the study.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Neutral sodium balance as assessed by ionic mass balance reduction in interdialytic weight gain.
Secondary outcome measures
Pre and post dialysis blood pressure, number of anti-hypertensive agents stability on dialysis, thirst score.
Overall trial start date
23/09/2002
Overall trial end date
23/03/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients on routine haemodialysis
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
We plan to enrol 60 - 100 patients currently established on haemodialysis.
Participant exclusion criteria
No documented exclusion criteria. Protocol specifies ALL patients on established haemodialysis.
Recruitment start date
23/09/2002
Recruitment end date
23/03/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Derby Hospitals NHS Foundation Trust (UK) NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list