Bicarbonate for Chronic Kidney Disease and Acidosis

Not Applicable

Completed

• Conditions: Chronic kidney disease; Urological and Genital Diseases

• Registration Number: ISRCTN09486651
• Lead Sponsor: Tayside Medical Sciences Centre (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26231610 2020 results in https://www.doi.org/10.1186/s12916-020-01542-9 (added 09/04/2020) 2020 HTA report in https://pubmed.ncbi.nlm.nih.gov/32568065/ (added 23/06/2020) 2021 secondary analysis of associations between frailty, physical performance, and renal biomarkers in https://pubmed.ncbi.nlm.nih.gov/33730363/ (added 18/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-17
• Study Completion: 2018-09-30
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Current inclusion criteria as of 10/07/2015:
1. Participant is willing and able to give informed consent for participation in the study
2. Male or female aged 60 years or above
3. Estimated Glomerular Filtration Rate (eGFR) <30 ml/min (i.e. CKD stages 4 and 5) found at screening visit
4. Serum Bicarbonate <22 mmol/L
5. Able (in the Investigators opinion) and willing to comply with all study requirements

Previous inclusion criteria:
1. Participant is willing and able to give informed consent for participation in the study
2. Male or female aged 65 years or above
3. Estimated Glomerular Filtration Rate (eGFR) <30 ml/min (i.e. CKD stages 4 and 5) found at screening visit
4. Serum Bicarbonate <22 mmol/L
5. Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria

Current exclusion criteria as of 10/07/2015:
1. Severe cognitive impairment precluding written informed consent
2. Already taking bicarbonate therapy; those taking bicarbonate therapy may be included after a 3 month washout period.
3. Documented renal tubular acidosis (such patients are likely to require bicarbonate, often in very large doses)
4. On renal replacement therapy (haemodialysis or peritoneal dialysis)
5. Anticipated to start renal replacement therapy within 3 months
6. Severe cognitive impairment precluding written informed consent
7. Participant who is terminally ill, as defined as less than 3 months expected survival
8. Decompensated chronic heart failure (to ensure that fluid overload is not exacerbated by the additional sodium load from the intervention)
9. Bisphosphonate therapy (to avoid obscuring bone turnover effects; patients with CKD stages 4/5 should not usually be taking bisphosphonates as this is a listed contraindication)
10. Uncontrolled hypertension (BP>150/90 despite use of four agents) unless evidence of well controlled blood pressure e.g. 24 hour BP readings or home readings

Previous exclusion criteria:
1. Severe cognitive impairment precluding written informed consent
2. Already taking bicarbonate therapy
3. Documented renal tubular acidosis (such patients are likely to require bicarbonate, often in very large doses)
4. On renal replacement therapy (haemodialysis or peritoneal dialysis)
5. Anticipated to start renal replacement therapy within 3 months
6. Severe cognitive impairment precluding written informed consent
7. Participant who is terminally ill, as defined as less than 3 months expected survival
8. Decompensated chronic heart failure (to ensure that fluid overload is not exacerbated by the additional sodium load from the intervention)
9. Bisphosphonate therapy (to avoid obscuring bone turnover effects; patients with CKD stages 4/5 should not usually be taking bisphosphonates as this is a listed contraindication)
10. Calcium carbonate use (to avoid interaction with bicarbonate)
11. Sevelamer hydrochloride use (to avoid increasing acid load)
12. Uncontrolled hypertension (BP>150/90 despite use of four agents)

Study & Design

• Study Type: Interventional
• Study Design: Not specified