| Source of record | UK Trials |
| ISRCTN | ISRCTN80601080 |
| Date ISRCTN assigned | 23/01/2008 |
| Local reference number(s) | SOB06/version3.0 |
| Public title | The effects of oral sodium bicarbonate on extracellular water in patients with chronic renal failure |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Chronic kidney disease |
| Study hypothesis | Does oral sodium bicarbonate have an effect on extracellular water or blood pressure in patients with chronic kidney disease? |
| Design/methodology | Randomised double blind placebo controlled trial |
| Research ethics review | Ethics approval received from the Hull and East Riding Local Research Ethics Committee on the 21st August 2006 (ref: 06/Q1104/108). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Chronic kidney disease (CKD) (creatinine greater than 180 mcmol/l or glomerular filtration rate [GFR] less than 60 ml/min)
2. Aged over 18 years, male and female |
| Participants - exclusion criteria | 1. Need for dialysis
2. Already taking oral sodium bicarbonate
3. Uncontrolled hypertension
4. Peripheral oedema
5. Nephrotic syndrome
6. Congestive cardiac failure |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet. |
| Anticipated start date | 06/06/2007 |
| Anticipated end date | 30/09/2008 |
| Status of trial | Ongoing |
| Target number of participants | 60 |
| Interventions | Oral sodium bicarbonate 1.5 g three times a day for 4 weeks versus placebo. Follow up is complete at the end of the 4-week treatment period. |
| Primary outcome measure(s) | Extracellular water and total body water measured by bromide space and deuterium dilution at 4 weeks. |
| Secondary outcome measure(s) | The following will be assessed at 4 weeks:
1. Blood pressure
2. Bio-impedance measures of total body water (TBW) and extracellular fluid (ECF) |
| Sources of funding | British Renal Society (UK) (ref: 05-008) |
| Sponsor name | York Hospitals NHS Trust (UK) |
| Sponsor details | York Hospital
Wigginton Road
York
United Kingdom
YO31 8HE |
| Sponsor email | caroline.mozley@york.nhs.uk |
| Sponsor website | http://www.yorkhealthservices.org/ |
| Contact name | Dr Colin Jones |
| Contact details | York Hospital
Wigginton Road
York
United Kingdom
YO31 8HE |
| Contact email | colin.h.jones@york.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN80601080 |
| Date last extracted from ISRCTN register | 17/04/2008 |
