Correction of metabolic acidosis in continuous ambulatory peritoneal dialysis patients with borderline dialysis adequacy - effect on nutritional status, systemic inflammatory response and patient morbidity

ISRCTN	ISRCTN35726272
DOI	https://doi.org/10.1186/ISRCTN35726272
Protocol serial number	931010
Sponsor	Hong Kong Health Services Research Fund (Hong Kong)
Funder	Hong Kong Health Services Research Fund (Hong Kong)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr CC Szeto
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Evaluate the effects of correcting acidosis by oral sodium bicarbonate in peritoneal dialysis patients with weekly Kt/V values below 2.1.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Sodium bicarbonate
Primary outcome measure(s)	1. Nutritional status 2. Total number of days in hospital admission during study period 3. All-cause mortality
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key 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)
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/12/2000
Date of final enrolment	01/04/2003

Department of Medicine & Therapeutics

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-
Hong Kong

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2003		Yes	No