Contact information
Type
Scientific
Primary contact
Dr Andrew Davenport
ORCID ID
Contact details
Department of Nephrology / Transplantation
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
+44 020 7794 0500 x 5689 or PA 5457
andrew.davenport@royalfree.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256183912
Study information
Scientific title
Acronym
Study hypothesis
Does dialysate sodium concentration affect sodium balance during haemodialysis, by altering the amount of sodium available for diffusion?
Ethics approval
Added June 2008: approved by University College Hospital Ethics Committee
Study design
Prospective cross over design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
dialystate sodium
Primary outcome measures
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 trial start date
01/03/2008
Overall trial end date
31/08/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
13 patients, study number reviewed by Dr Morris, statistician population sciences The Royal Free Hospital.
Participant exclusion criteria
Added June 2008:
1. Unable to provide informed consent
2. Unstable on dialysis
3. Dialysis frequency < or > 3 x per week
Recruitment start date
01/03/2008
Recruitment end date
31/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Nephrology / Transplantation
London
NW3 2QG
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
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
The Royal Free Hampstead NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Special Trustees
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
Results - basic reporting
Publication summary
1. 2010 results in www.ncbi.nlm.nih.gov/pubmed/21077042
Publication citations
-
Results
Davenport A, Negative dialysate to sodium gradient does not lead to intracellular volume expansion post hemodialysis., Int J Artif Organs, 2010, 33, 10, 700-705.