Effect of dialystate sodium concentration on intracellular and extracellular fluid volumes in regular chronic haemodialysis (HD) patients

ISRCTN	ISRCTN14411549
DOI	https://doi.org/10.1186/ISRCTN14411549
Secondary identifying numbers	N0256183912

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Andrew Davenport
Scientific

Department of Nephrology / Transplantation
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Phone	+44 020 7794 0500 x 5689 or PA 5457
Email	andrew.davenport@royalfree.nhs.uk

Study design	Prospective cross over design
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Does dialysate sodium concentration affect sodium balance during haemodialysis, by altering the amount of sodium available for diffusion?
Ethics approval(s)	Added June 2008: approved by University College Hospital Ethics Committee
Health condition(s) or problem(s) studied	Urological and Genital Diseases: Haemodialysis
Intervention	Each patient will dialyse against three different dialysate sodium concentrations. The sequence will be randomised. Until June 2008, trial dates were 01/04/2006 to 01/10/2007.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	dialystate sodium
Primary outcome measure	Intracellular and extracellular fluid volume changes, effluent dialysate sodium, interdialytic weight grain, predialysis blood pressure, intradialytic blood pressure, intradialytic blood volume changes.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/03/2008
Completion date	31/08/2009

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	13 patients, study number reviewed by Dr Morris, statistician population sciences The Royal Free Hospital.
Key inclusion criteria	Added June 2008: 1. 18 years or older 2. Stable on dialysis 3. 3 x week HD patients 4. Able to provide informed consent
Key exclusion criteria	Added June 2008: 1. Unable to provide informed consent 2. Unstable on dialysis 3. Dialysis frequency < or > 3 x per week
Date of first enrolment	01/03/2008
Date of final enrolment	31/08/2009

Department of Nephrology / Transplantation

London
NW3 2QG
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

The Royal Free Hampstead NHS Trust (UK)

No information available

Special Trustees

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2010		Yes	No