Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/10/2002
Date assigned
10/10/2002
Last edited
02/07/2009
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 CC Szeto

ORCID ID

Contact details

Department of Medicine & Therapeutics
Prince of Wales Hospital
Chinese University of Hong Kong
-
-
Hong Kong

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

  1. 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.

Additional files

Editorial Notes