104 Oral Sodium Bicarbonate Therapy for Older Patients with Chronic Kidney Disease and Low-Grade Acidosis: The BiCARB Randomised Controlled Trial

2020 ◽  
Vol 49 (Supplement_1) ◽  
pp. i34-i36
Author(s):  
M D Witham ◽  
M Band ◽  
H Chong ◽  
P T Donnan ◽  
G Hampson ◽  
...  

Abstract Background Oral sodium bicarbonate is often used to treat metabolic acidosis in older people with advanced chronic kidney disease, but evidence is lacking on whether this provides a net gain in health or quality of life. Methods We conducted a multicentre, parallel group, double-blind, placebo-controlled randomised trial. Adults aged 60 years and over with category 4 or 5 chronic kidney disease, not on dialysis, with serum bicarbonate concentrations <22 mmol/L were recruited from 27 UK centres. Participants were randomised 1:1 to oral sodium bicarbonate or matching placebo. The primary outcome was the between-group difference in the Short Physical Performance Battery at 12 months, adjusted for baseline. Other key outcome measures included generic and disease-specific health-related quality of life, anthropometry, physical performance, renal function, adverse events including commencement of renal replacement therapy, and health economic analysis. Results We randomised 300 participants, mean age 74 years; 86 (29%) were female. Mean baseline estimated GFR was 19 ml/min/1.73m2. Study medication adherence was 73% in both groups. No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery at 12 months (-0.4 points; 95% CI -0.9 to 0.1, p=0.15). No significant treatment benefit was seen for any of the secondary outcomes. Adverse events were more frequent in the bicarbonate arm (457 versus 400). Time to commencing renal replacement therapy was similar in both groups (HR 1.22, 95% CI 0.74 to 2.02, p=0.43). Health economic analysis showed lower quality of life and higher costs in the bicarbonate arm at one year (£1234 vs £807); placebo dominated bicarbonate under all sensitivity analyses for incremental cost-effectiveness. Conclusions Oral sodium bicarbonate did not improve a wide range of health measures in this trial, and is unlikely to be cost-effective for use in the UK NHS in this patient group.

2020 ◽  
Vol 24 (27) ◽  
pp. 1-90 ◽  
Author(s):  
Miles D Witham ◽  
Margaret Band ◽  
Huey Chong ◽  
Peter T Donnan ◽  
Geeta Hampson ◽  
...  

Background Advanced chronic kidney disease is common in older people and is frequently accompanied by metabolic acidosis. Oral sodium bicarbonate is used to treat this acidosis, but evidence is lacking on whether or not this provides a net gain in health or quality of life for older people. Objectives The objectives were to determine whether or not oral bicarbonate therapy improves physical function, quality of life, markers of renal function, bone turnover and vascular health compared with placebo in older people with chronic kidney disease and mild acidosis; to assess the safety of oral bicarbonate; and to establish whether or not oral bicarbonate therapy is cost-effective in this setting. Design A parallel-group, double-blind, placebo-controlled randomised trial. Setting The setting was nephrology and geriatric medicine outpatient departments in 27 UK hospitals. Participants Participants were adults aged ≥ 60 years with advanced chronic kidney disease (glomerular filtration rate category 4 or 5, not on dialysis) with a serum bicarbonate concentration of < 22 mmol/l. Interventions Eligible participants were randomised 1 : 1 to oral sodium bicarbonate or matching placebo. Dosing started at 500 mg three times daily, increasing to 1 g three times daily if the serum bicarbonate concentration was < 22 mmol/l at 3 months. Main outcome measures The primary outcome was the between-group difference in the Short Physical Performance Battery score at 12 months, adjusted for baseline. Other outcome measures included generic and disease-specific health-related quality of life, anthropometry, 6-minute walk speed, grip strength, renal function, markers of bone turnover, blood pressure and brain natriuretic peptide. All adverse events were recorded, including commencement of renal replacement therapy. For the health economic analysis, the incremental cost per quality-adjusted life-year was the main outcome. Results In total, 300 participants were randomised, 152 to bicarbonate and 148 to placebo. The mean age of participants was 74 years and 86 (29%) were female. Adherence to study medication was 73% in both groups. A total of 220 (73%) participants were assessed at the 12-month visit. No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery score at 12 months (–0.4 points, 95% confidence interval –0.9 to 0.1 points; p = 0.15). No significant treatment benefit was seen for any of the secondary outcomes. Adverse events were more frequent in the bicarbonate arm (457 vs. 400). Time to commencement of renal replacement therapy was similar in both groups (hazard ratio 1.22, 95% confidence interval 0.74 to 2.02; p = 0.43). Health economic analysis showed higher costs and lower quality of life in the bicarbonate arm at 1 year, with additional costs of £564 (95% confidence interval £88 to £1154) and a quality-adjusted life-year difference of –0.05 (95% confidence interval –0.08 to –0.01); placebo dominated bicarbonate under all sensitivity analyses for incremental cost-effectiveness. Limitations The trial population was predominantly white and male, limiting generalisability. The increment in serum bicarbonate concentrations achieved was small and a benefit from larger doses of bicarbonate cannot be excluded. Conclusions Oral sodium bicarbonate did not improve a range of health measures in people aged ≥ 60 years with chronic kidney disease category 4 or 5 and mild acidosis, and is unlikely to be cost-effective for use in the NHS in this patient group. Once other current trials of bicarbonate therapy in chronic kidney disease are complete, an individual participant meta-analysis would be helpful to determine which subgroups, if any, are more likely to benefit and which treatment regimens are more beneficial. Trial registration Current Controlled Trials ISRCTN09486651 and EudraCT 2011-005271-16. The systematic review is registered as PROSPERO CRD42018112908. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 27. See the NIHR Journals Library website for further project information.


2020 ◽  
Vol 20 (S1) ◽  
Author(s):  
Rada Artzi-Medvedik ◽  
◽  
Robert Kob ◽  
Paolo Fabbietti ◽  
Fabrizia Lattanzio ◽  
...  

Abstract Background Quality of life (QoL) refers to the physical, psychological, social and medical aspects of life that are influenced by health status and function. The purpose of this study was to measure the self-perceived health status among the elderly population across Europe in different stages of Chronic Kidney Disease (CKD). Methods Our series consisted of 2255 community-dwelling older adults enrolled in the Screening for Chronic Kidney Disease (CKD) among Older People across Europe (SCOPE) study. All patients underwent a comprehensive geriatric assessment (CGA), including included demographics, clinical and physical assessment, number of medications taken, family arrangement, Geriatric Depression Scale (GDS), Cumulative Illness Rating Scale, History of falls, Lower urinary tract symptoms, and Short Physical Performance Battery (SPPB). Estimated glomerular filtration rate (eGFR) was calculated by Berlin Initiative Study (BIS) equation. Quality of life was assessed by Euro Qol questionnaire (Euro-Qol 5D) and EQ-Visual Analogue Scale (EQ-VAS). The association between CKD (eGFR < 60, < 45 ml or < 30 ml/min/1.73m2) and low EQoL-VAS was investigated by multivariable logistic regression models. Results CKD was found to be significantly associated with low EQoL-VAS in crude analysis (OR = 1.47, 95%CI = 1.16–1.85 for eGFR< 60; OR = 1.38, 95%CI = 1.08–1.77 for eGFR< 45; OR = 1.57, 95%CI = 1.01–2.44). Such association was no longer significant only when adjusting for SPPB (OR = 1.20, 95%CI = 0.93–1.56 for eGFR< 60; OR = 0.87, 95%CI = 0.64–1.18 for eGFR< 45; OR = 0.84, 95%CI = 0.50–1.42), CIRS and polypharmacy (OR = 1.16, 95%CI = 0.90–1.50 for eGFR< 60; OR = 0.86, 95%CI = 0.64–1.16 for eGFR< 45; OR = 1.11, 95%CI = 0.69–1.80) or diabetes, hypertension and chronic obstructive pulmonary disease (OR = 1.28, 95%CI = 0.99–1.64 for eGFR< 60; OR = 1.16, 95%CI = 0.88–1.52 for eGFR< 45; OR = 1.47, 95%CI = 0.92–2.34). The association between CKD and low EQoL-VAS was confirmed in all remaining multivariable models. Conclusions CKD may significantly affect QoL in community-dwelling older adults. Physical performance, polypharmacy, diabetes, hypertension and COPD may affect such association, which suggests that the impact of CKD on QoL is likely multifactorial and partly mediated by co-occurrent conditions/risk factors.


2018 ◽  
Vol 5 (2) ◽  
pp. 56-63
Author(s):  
Abdul Wakhid ◽  
Estri Linda Wijayanti ◽  
Liyanovitasari Liyanovitasari

Background: Self efficacy can optimize the quality of life of clients who undergo the healing process due to chronic diseases. Individuals with higher self-efficacy move their personal and social resources proactively to maintain and improve the quality and length of their lives so that they experience a better quality of life. Objectives: the purpose of this study was to find the correlation between self efficacy and quality of life of patients with chronic kidney disease who undergo hemodialysis at RSUD Semarang Regency. Metode: This type of research was descriptive correlation with cross sectional approach. The samples in this study more 76 people with total sampling technique. The data collection tool for self efficacy was measured by General Self-Efficacy scale, for quality of life with WHOQoL-BREF. Statistical test used Kolmogorov-smirnov. Result: The result showed that self efficacy in patients with chronic kidney disease was mostly in moderate category (53,9%), quality of life in patients with chronic kidney disease was mostly in good category (68,4%). There was a correlation between self efficacy and quality of life of patients with chronic kidney disease who undergo hemodialysis at RSUD Semarang Regency, the result obtained p-value of 0.000 <α (0,05). Suggestion: Patients with chronic kidney disease can maintain good quality of life by helping to generate positive self-esteem and high self efficacy.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan Shen ◽  
◽  
Jinwei Wang ◽  
Jing Yuan ◽  
Li Yang ◽  
...  

Abstract Background Anemia is one of the common complications in patients with chronic kidney disease (CKD). However, there is no systematic investigation on the prevalence of anemia in CKD patients and its relationship with the quality of life in China. Methods The data for this study comes from baseline data from the Chinese Chronic Kidney Disease Cohort Study (C-STRIDE), which recruited predialysis CKD patients in China. The kidney disease quality of life summary (KDQOL-TM) was used to assess health-related quality of life (HRQoL). Use linear regression model to estimate the relationship between hemoglobin level and quality of life. Results A total of 2921 patients were included in this study. The adjusted prevalence of hemoglobin (Hb) less than 100 g/L was 10.3% (95% confidence interval [CI]: 9.9,11.4%), and showed an increased trend through reduced eGFR levels from 4.0% (95%CI:2.3,5.9%) in the 45-60 ml/min/1.73m2 group to 23.4% (95%CI:20.5,26.2%) in the 15–29 ml/min/1.73m2 group. The prevalence of anti-anemia treatment was 34.0% (95%CI: 28.7,39.3%) and it is shown by reducing eGFR levels from 15.8% (95%CI:0,36.7%) in the 45-60 ml/min/1.73m2 group to 38.2% (95%CI: 30.7,45.2%) in the 15–29 ml/min/1.73m2 group. All five dimensions of the KDQOL scores in patients with CKD decreased as hemoglobin declined. After multivariable adjustments,the degrees of decrease became somewhat blunted. For example, compared with hemoglobin of ≥130 g/L, regression coefficients in the hemoglobin of < 100 g/L were − 0.047(95%CI: − 0.049,-0.045) for Symptoms and Problems(S), − 0.047(95%CI: − 0.049,-0.044) for Effects of the Kidney Disease(E), − 0.207(95%CI: − 0.212,-0.203) for Burden of the Kidney Disease(B), − 0.112(95%CI: − 0.115,-0.109) for SF-12 Physical Functioning (PCS), − 0.295(95%CI: − 0.299, -0.292) for SF-12 Mental Functioning (MCS), respectively. Conclusions In our cross-sectional analysis of patients with CKD in China, prevalence of both anemia and anti-anemia treatment increased with decreased eGFR. In addition, anemia was associated with reduced HRQoL.


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