ISRCTN09486651已完成未知
Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis?
Tayside Medical Sciences Centre (UK)0 个研究点目标入组 300 人开始时间: 2012年2月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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