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 |
| Secondary identifying numbers | 931010 |
- Submission date
- 10/10/2002
- Registration date
- 10/10/2002
- Last edited
- 02/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr CC Szeto
Scientific
Scientific
Department of Medicine & Therapeutics
Prince of Wales Hospital
Chinese University of Hong Kong
-
-
Hong Kong
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sodium bicarbonate |
| Primary outcome measure | 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 study start date | 01/12/2000 |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Department of Medicine & Therapeutics
-
-
Hong Kong
-
Hong Kong
Sponsor information
Hong Kong Health Services Research Fund (Hong Kong)
Government
Government
Health Welfare and Food Bureau
Government Secretariat, HKSAR
20th floor Murray Building
Garden Road
-
-
Hong Kong
| Phone | +852 (0)2973 8288 |
|---|---|
| hsrf@hwfb.gov.hk | |
| Website | http://www.fhb.gov.hk/grants/english/funds/funds_hhsrf/funds_hhsrf_abt/funds_hhsrf_abt.html |
"ROR" |
https://ror.org/03qh32912 |
Funders
Funder type
Government
Hong Kong Health Services Research Fund (Hong Kong)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2003 | Yes | No |
