Correction of acidosis in chronic kidney disease (CKD)
| ISRCTN | ISRCTN17109689 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17109689 |
| Secondary identifying numbers | P/01/211 |
- Submission date
- 03/12/2007
- Registration date
- 18/01/2008
- Last edited
- 04/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Muhammad Magdi Yaqoob
Scientific
Scientific
Renal Unit
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Study information
| Study design | Randomised prospective parallel group study of patients in stage 4 and 5 CKD |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Effects on progression of renal failure and nutritional status by correction of metabolic acidosis in patients with non-dialysis dependent chronic kidney disease (CKD) |
| Study objectives | Experimental data suggest that acidosis induced excessive renal ammoniagenesis and activation of the complement cascade by the alternative pathway, lead to rapid progression of renal failure which can be attenuated by bicarbonate supplementation. Moreover, metabolic acidosis accelerates protein catabolism and causes malnutrition due to an induced negative nitrogen balance in patients with end-stage renal disease (ESRD). We propose that correction of acidosis will attenuate the progression of renal failure and will improve nutritional status in patients with non-dialysis dependent chronic kidney disease. |
| Ethics approval(s) | The study is approved by the Local Research Ethics Committee from April 2002 to July 2006 (ref: P/01/211). |
| Health condition(s) or problem(s) studied | Chronic kidney disease |
| Intervention | Sodium bicarbonate versus no treatment. Duration of treatment: 2 years Method of intake: oral Frequency of treatment: daily 600 mg three times a day to be titrated up by 600 mg till serum biocarbonate level of greater than 21 mmol/l were achieved Duration of follow up: 2 years |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sodium bicarbonate |
| Primary outcome measure | The primary end points were number of patients reaching ESRD and rate of decline of estimated glomerular filtration rate (eGFR) by Cockroft-Gault equation and creatinine clearance (Cr Cl) (24 hours urine sample). Primary end points are measured every three months. |
| Secondary outcome measures | Nutritional parameters assessed by: 1. Dietary protein intake 2. Protein catabolic rate (PCR) 3. Serum albumin 4. Mid-arm muscle circumference (MAMC) Secondary end points measured every six months. |
| Overall study start date | 30/04/2002 |
| Completion date | 30/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 134 |
| Key inclusion criteria | 1. Age greater than 18 years old 2. CKD stage 4 and 5 3. Mild to moderate metabolic acidosis (serum bicarbonate less than 21 and greater than 16 mmol/L) on two consecutive measurements 4. Stable clinical condition |
| Key exclusion criteria | Patients with: 1. Malignant disease 2. Morbid obesity 3. Cognitive impairment 4. Chronic sepsis 5. Poorly controlled blood pressure (greater than 150/90 mmHg), despite use of four agents 6. Overt congestive heart failure |
| Date of first enrolment | 30/04/2002 |
| Date of final enrolment | 30/07/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Renal Unit
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Barts and the London NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Gerry Leanord
Research and Development Directorate
Whitechapel
London
E1 1BB
England
United Kingdom
| Website | http://www.bartsandthelondon.org.uk/ |
|---|---|
"ROR" |
https://ror.org/00b31g692 |
Funders
Funder type
Government
Barts and the London NHS Trust (UK)
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 | 01/09/2009 | Yes | No |
