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 |
| Protocol serial number | N0256183912 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | The Royal Free Hampstead NHS Trust (UK), Special Trustees |
- 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
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 |
|---|---|
| andrew.davenport@royalfree.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective cross over design |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | dialystate sodium |
| Primary outcome measure(s) |
Intracellular and extracellular fluid volume changes, effluent dialysate sodium, interdialytic weight grain, predialysis blood pressure, intradialytic blood pressure, intradialytic blood volume changes. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 13 |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Nephrology / Transplantation
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
