Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis (the BiCARB trial)? Study protocol for a randomized controlled trial

Trials

Volumn 16, Issue 1, 2015, Pages

  Witham, Miles D ^a   Band, Margaret M ^a   Littleford, Roberta C ^a   Avenell, Alison ^b   Soiza, Roy L ^b   McMurdo, Marion E T ^a   Sumukadas, Deepa ^a   Ogston, Simon A ^a   Lamb, Edmund J ^c   Hampson, Geeta ^d   McNamee, Paul ^e  

^a UNIVERSITY OF DUNDEE   (United Kingdom)

^b UNIVERSITY OF ABERDEEN   (United Kingdom)

^c EAST KENT HOSPITALS UNIVERSITY NHS FOUNDATION TRUST   (United Kingdom)

^d GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^e UNIVERSITY OF ABERDEEN   (United Kingdom)

Author keywords

Bicarbonate; Chronic kidney disease; Metabolic acidosis; Older; Physical function; Quality of life; Randomised controlled trial

Indexed keywords

1,25 HYDROXYVITAMIN D; 25 HYDROXYVITAMIN D; ACID PHOSPHATASE TARTRATE RESISTANT ISOENZYME; ALKALINE PHOSPHATASE; BICARBONATE; BRAIN NATRIURETIC PEPTIDE; PLACEBO; UNCLASSIFIED DRUG; VITAMIN D; BIOLOGICAL MARKER;

ADULT; ALBUMINURIA; ARTICLE; BICARBONATE BLOOD LEVEL; BLOOD PRESSURE; BONE TURNOVER; CHRONIC KIDNEY DISEASE; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; FEMALE; GLOMERULUS FILTRATION RATE; HUMAN; KIDNEY FUNCTION; LOW GRADE ACIDOSIS; MAJOR CLINICAL STUDY; MALE; METABOLIC ACIDOSIS; MULTICENTER STUDY; MUSCLE STRENGTH; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; VITAMIN BLOOD LEVEL; ACID BASE BALANCE; ACIDOSIS; AGE; BLOOD; CLINICAL PROTOCOL; CLINICAL TRIAL; COMPLICATION; COST BENEFIT ANALYSIS; DRUG COST; DRUG EFFECTS; ECONOMICS; HEALTH STATUS; KIDNEY; METHODOLOGY; MIDDLE AGED; ORAL DRUG ADMINISTRATION; PATHOPHYSIOLOGY; PSYCHOLOGY; QUESTIONNAIRE; RENAL INSUFFICIENCY, CHRONIC; SEVERITY OF ILLNESS INDEX; TIME FACTOR; TREATMENT OUTCOME; UNITED KINGDOM;

ACID-BASE EQUILIBRIUM; ACIDOSIS; ADMINISTRATION, ORAL; AGE FACTORS; BIOMARKERS; CLINICAL PROTOCOLS; COST-BENEFIT ANALYSIS; DOUBLE-BLIND METHOD; DRUG COSTS; FEMALE; GLOMERULAR FILTRATION RATE; HEALTH STATUS; HUMANS; KIDNEY; MALE; MIDDLE AGED; MUSCLE STRENGTH; QUALITY OF LIFE; RENAL INSUFFICIENCY, CHRONIC; RESEARCH DESIGN; SEVERITY OF ILLNESS INDEX; SODIUM BICARBONATE; SURVEYS AND QUESTIONNAIRES; TIME FACTORS; TREATMENT OUTCOME; UNITED KINGDOM;

EID: 84938061341     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0843-6     Document Type: Article

References (36)

1. Coresh J, Astor BC, Greene T, Eknoyan G, Levey AS. Prevalence of chronic kidney disease and decreased kidney function in the adult US population: Third National Health and Nutrition Examination Survey. Am J Kidney Dis. 2003;41:1-12.
2. Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, et al. Prevalence of chronic kidney disease in the United States. JAMA. 2007;298:2038-47.
3. Eustace JA, Astor B, Muntner PM, Ikizler TA, Coresh J. Prevalence of acidosis and inflammation and their association with low serum albumin in chronic kidney disease. Kidney Int. 2004;65:1031-40.
4. Dobre M, Rahman M, Hostetter TH. Current status of Bicarbonate in CKD. J Am Soc Nephrol. 2015;26:515-23.
5. Hughes LD, McMurdo ME, Guthrie B. Guidelines for people not for diseases: the challenges of applying UK clinical guidelines to people with multimorbidity. Age Ageing. 2013;42:62-9.
6. Stevens PE, Lamb EJ, Levin A. Integrating guidelines, CKD, multimorbidity and older adults. Am J Kidney Dis. 2015;65:494-501.
7. Kraut JA, Kurtz I. Metabolic acidosis of CKD: diagnosis, clinical characteristics, and treatment. Am J Kidney Dis. 2005;45:978-93.
8. Workeneh BT, Mitch WE. Review of muscle wasting associated with chronic kidney disease. Am J Clin Nutr. 2010;91:1128S-32S.
9. Ceglia L, Harris SS, Abrams SA, Rasmussen HM, Dallal GE, Dawson-Hughes B. Potassium bicarbonate attenuates the urinary nitrogen excretion that accompanies an increase in dietary protein and may promote calcium absorption. J Clin Endocrinol Metab. 2009;94:645-53.
10. Kraut JA. Disturbances of acid-base balance and bone disease in end-stage renal disease. Semin Dial. 2000;13:261-6.
11. Reaich D, Graham KA, Channon SM, Hetherington C, Scrimgeour CM, Wilkinson R, et al. Insulin-mediated changes in PD and glucose uptake after correction of acidosis in humans with CRF. Am J Physiol. 1995;268:E121-6.
12. Wiederkehr MR, Kalogiros J, Krapf R. Correction of metabolic acidosis improves thyroid and growth hormone axes in haemodialysis patients. Nephrol Dial Transplant. 2004;19:1190-7.
13. Brito-Ashurst I, Varagunam M, Raftery MJ, Yaqoob MM. Bicarbonate supplementation slows progression of CKD and improves nutritional status. J Am Soc Nephrol. 2009;20:2075-84.
14. Menon V, Tighiouart H, Vaughn NS, Beck GJ, Kusek JW, Collins AJ, et al. Serum bicarbonate and long-term outcomes in CKD. Am J Kidney Dis. 2010;56:907-14.
15. Bibbins-Domingo K, Chertow GM, Coxson PG, Moran A, Lightwood JM, Pletcher MJ, et al. Projected effect of dietary salt reductions on future cardiovascular disease. N Engl J Med. 2010;362:590-9.
16. Dobre M, Yang W, Chen J, Drawz P, Hamm LL, Horwitz E, et al. Association of Serum Bicarbonate With Risk of Renal and Cardiovascular Outcomes in CKD: A Report From the Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Kidney Dis. 2013;62:670-8.
17. Roberts H, Khee TS, Philip I. Setting priorities for measures of performance for geriatric medical services. Age Ageing. 1994;23:154-7.
18. Susantitaphong P, Sewaralthahab K, Balk EM, Jaber BL, Madias NE. Short- and long-term effects of alkali therapy in chronic kidney disease: a systematic review. Am J Nephrol. 2012;35:540-7.
19. Mahajan A, Simoni J, Sheather SJ, Broglio KR, Rajab MH, Wesson DE. Daily oral sodium bicarbonate preserves glomerular filtration rate by slowing its decline in early hypertensive nephropathy. Kidney Int. 2010;78:303-9.
20. Laukkanen P, Heikkinen E, Kauppinen M. Muscle strength and mobility as predictors of survival in 75-84-year-old people. Age Ageing. 1995;24:468-73.
21. Rantanen T, Avlund K, Suominen H, Schroll M, Frandin K, Pertti E. Muscle strength as a predictor of onset of ADL dependence in people aged 75 years. Aging Clin Exp Res. 2002;14(3 Suppl):10-5.
22. Johnston AT, Barnsdale L, Smith R, Duncan K, Hutchison JD. Change in long-term mortality associated with fractures of the hip: evidence from the scottish hip fracture audit. J Bone Joint Surg. 2010;92:989-93.
23. Davis JC, Robertson MC, Ashe MC, Liu-Ambrose T, Khan KM, Marra CA. International comparison of cost of falls in older adults living in the community: a systematic review. Osteoporos Int. 2010;21:1295-306.
24. Baboolal K, McEwan P, Sondhi S, Spiewanowski P, Wechowski J, Wilson K. The cost of renal dialysis in a UK setting--a multicentre study. Nephrol Dial Transplant. 2008;23(6):1982-9.
25. Kamper AM, Stott DJ, Hyland M, Murray HM, Ford I. Predictors of functional decline in elderly people with vascular risk factors or disease. Age Ageing. 2005;34:450-5.
26. Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008;2:CD000011.
27. Wennie Huang WN, Perera S, Vanswearingen J, Studenski S. Performance Measures Predict Onset of Activity of Daily Living Difficulty in Community-Dwelling Older Adults. J Am Geriatr Soc. 2010;58:844-52.
28. Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995;332:556-61.
29. Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994;49:M85-94.
30. Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994;3:329-38.
31. van Hout BA, Al MJ, Gordon GS, Rutten FF. Costs, effects and C/E-ratios alongside a clinical trial. Health Econ. 1994;3:309-19.
32. McMurdo ME, Sugden J, Argo I, Boyle P, Johnston DW, Sniehotta FF, et al. Do pedometers increase physical activity in sedentary older women? A randomized controlled trial. J Am Geriatr Soc. 2010;58:2099-106.
33. Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005;14:1523-32.
34. McMurdo ME, Witham MD, Gillespie ND. Including older people in clinical research. BMJ. 2005;331:1036-7.
35. Di Iorio B, Aucella F, Conte G, Cupisti A, Santoro D. A prospective, multicenter, randomized, controlled study: the correction of metabolic acidosis with use of bicarbonate in Chronic Renal Insufficiency (UBI) Study. J Nephrol. 2012;25:437-40.
36. Gaggl M, Cejka D, Plischke M, Heinze G, Fraunschiel M, Schmidt A, et al. Effect of oral sodium bicarbonate supplementation on progression of chronic kidney disease in patients with chronic metabolic acidosis: study protocol for a randomized controlled trial (SoBic-Study). Trials. 2013;14:196.