Condition category
Urological and Genital Diseases
Date applied
04/09/2007
Date assigned
23/01/2008
Last edited
16/02/2015
Prospective/Retrospective
Retrospectively 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 Colin Jones

ORCID ID

Contact details

York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
-
colin.h.jones@york.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SOB06/version3.0

Study information

Scientific title

The effects of oral sodium bicarbonate on extracellular water in patients with chronic renal failure

Acronym

Study hypothesis

Does oral sodium bicarbonate have an effect on extracellular water or blood pressure in patients with chronic kidney disease?

On 14/02/2012 an update was received stating that the trial end date was extended following a trial halt period. Trial was terminated early on 21/11/2011 at 40 subjects due to inability to recruit sufficient patients within a reasonable timescale. Relevant authorities have been notified. Sample analysis is currently taking place. Statistical analysis and publication of results will follow later this year.

On 15/02/2012 the overall trial end date was changed from 30/09/2008 to 21/11/2011.

Ethics approval

Hull and East Riding Local Research Ethics Committee, 21/08/2006, ref: 06/Q1104/108

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Chronic kidney disease

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Sodium bicarbonate

Primary outcome measures

Extracellular water and total body water measured by bromide space and deuterium dilution at 4 weeks.

Secondary outcome measures

The following will be assessed at 4 weeks:
1. Blood pressure
2. Bio-impedance measures of total body water (TBW) and extracellular fluid (ECF)

Overall trial start date

06/06/2007

Overall trial end date

21/11/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

06/06/2007

Recruitment end date

21/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

York Hospital
York
YO31 8HE
United Kingdom

Sponsor information

Organisation

York Hospitals NHS Trust (UK)

Sponsor details

York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
-
caroline.mozley@york.nhs.uk

Sponsor type

Government

Website

http://www.yorkhealthservices.org/

Funders

Funder type

Charity

Funder name

British Renal Society (UK) (ref: 05-008)

Alternative name(s)

BRS

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes