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
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
07/09/2012
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 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 information

Study designProspective cross over design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesDoes 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) studiedUrological and Genital Diseases: Haemodialysis
InterventionEach 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)dialystate sodium
Primary outcome measureIntracellular and extracellular fluid volume changes, effluent dialysate sodium, interdialytic weight grain, predialysis blood pressure, intradialytic blood pressure, intradialytic blood volume changes.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2008
Completion date31/08/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
Lower age limit18 Years
SexNot Specified
Target number of participants13 patients, study number reviewed by Dr Morris, statistician population sciences The Royal Free Hospital.
Key inclusion criteriaAdded 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 criteriaAdded June 2008:
1. Unable to provide informed consent
2. Unstable on dialysis
3. Dialysis frequency < or > 3 x per week
Date of first enrolment01/03/2008
Date of final enrolment31/08/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Nephrology / Transplantation
London
NW3 2QG
United Kingdom

Sponsor information

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

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

The Royal Free Hampstead NHS Trust (UK)

No information available

Special Trustees

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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