Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
931010
Study information
Scientific title
Acronym
Study hypothesis
Evaluate the effects of correcting acidosis by oral sodium bicarbonate in peritoneal dialysis patients with weekly Kt/V values below 2.1.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Metabolic acidosis
Intervention
Patients will be randomised to receive either:
1. Oral sodium bicarbonate 0.9 g three times a day (tds)
2. Placebo
Patients were followed up for 12 months.
Intervention type
Drug
Phase
Not Specified
Drug names
Sodium bicarbonate
Primary outcome measures
1. Nutritional status
2. Total number of days in hospital admission during study period
3. All-cause mortality
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2000
Overall trial end date
01/04/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. End-stage renal failure patients
2. Receiving Continuous Ambulatory Peritoneal Dialysis (CAPD)
3. Weekly Kt/V 1.6 to 1.9
4. Metabolic acidosis (plasma bicarbonate less than 24 mmol/l)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/12/2000
Recruitment end date
01/04/2003
Locations
Countries of recruitment
Hong Kong
Trial participating centre
Department of Medicine & Therapeutics
-
-
Hong Kong
Sponsor information
Organisation
Hong Kong Health Services Research Fund (Hong Kong)
Sponsor details
Health Welfare and Food Bureau
Government Secretariat
HKSAR
20th floor Murray Building
Garden Road
-
-
Hong Kong
+852 (0)2973 8288
hsrf@hwfb.gov.hk
Sponsor type
Government
Website
http://www.fhb.gov.hk/grants/english/funds/funds_hhsrf/funds_hhsrf_abt/funds_hhsrf_abt.html
Funders
Funder type
Government
Funder name
Hong Kong Health Services Research Fund (Hong Kong)
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
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12874466
Publication citations
-
Results
Szeto CC, Wong TY, Chow KM, Leung CB, Li PK, Oral sodium bicarbonate for the treatment of metabolic acidosis in peritoneal dialysis patients: a randomized placebo-control trial., J. Am. Soc. Nephrol., 2003, 14, 8, 2119-2126.