Study into achievement of isonatric haemodialysis by individual tailoring of dialysate sodium according to ionic mass balance derived from online conductance monitoring

ISRCTN	ISRCTN71215609
DOI	https://doi.org/10.1186/ISRCTN71215609
Secondary identifying numbers	N0077114320

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 16/04/2015

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chris W McIntyre
Scientific

Derby Hospitals NHS Foundation Trust
Department of Nephrology
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Study into achievement of isonatric haemodialysis by individual tailoring of dialysate sodium according to ionic mass balance derived from online conductance monitoring
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	23/09/2002
Completion date	23/03/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	We plan to enrol 60 - 100 patients currently established on haemodialysis.
Key inclusion criteria	Patients on routine haemodialysis
Key exclusion criteria	No documented exclusion criteria. Protocol specifies ALL patients on established haemodialysis.
Date of first enrolment	23/09/2002
Date of final enrolment	23/03/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Derby Hospitals NHS Foundation Trust

Derby
DE22 3NE
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Derby Hospitals NHS Foundation Trust (UK) NHS R&D Support Funding

No information available

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