Condition category
Urological and Genital Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
07/09/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes