Rationale and design of the Sodium Lowering In Dialysate (SoLID) trial: a randomised controlled trial of low versus standard dialysate sodium concentration during hemodialysis for regression of left ventricular mass

BMC Nephrology

Mark Roger Marshall⁷  David John Semple³  Kannaiyan Samuel Rabindranath⁶  David Owen Ross McGregor²  Philip James Matheson⁴  Christopher John Hood⁷  Imad Adbi Haloob³  Ruvin Sampath Gabriel⁵  Janak Rashme de Zoysa⁸  Alain Charles Vandal¹  Joanna Leigh Dunlop⁷ 

[1] Faculty of Health and Environmental Sciences, Auckland University of Technology, North Shore Campus, Private Bag 92006, Auckland 1142, New Zealand;Department of Nephrology, Christchurch Hospital, Canterbury District Health Board, Private Bag 4710, Christchurch, New Zealand;Department of Renal Medicine, Auckland City Hospital, Auckland District Health Board, Private Bag 92024, Auckland 0740, New Zealand;Department of Nephrology, Wellington Hospital, Capital & Coast District Health Board, Private Bag 7902, Wellington South, New Zealand;Department of Cardiology, Middlemore Hospital, Counties Manukau District Health Board, Private Bag 93311, Otahuhu, Auckland 1640, New Zealand;Department of Renal Medicine, Waikato Hospital, Waikato District Health Board, Private Bag 3200, Hamilton 3240, New Zealand;Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Private Bag 93311, Otahuhu, Auckland 1640, New Zealand;Renal Service, North Shore Hospital, Waitemata District Health Board, Private Bag 93503, Takapuna, Auckland 0740, New Zealand

关键词: Dialysate;    Fluid overload;    Blood pressure;    Sodium;    Left ventricular mass;    Dialysis;    Home hemodialysis;   

Others  :  1082890
DOI  :  10.1186/1471-2369-14-149

 received in 2013-04-22, accepted in 2013-07-08,  发布年份 2013

【 摘 要 】

Background

The current literature recognises that left ventricular hypertrophy makes a key contribution to the high rate of premature cardiovascular mortality in dialysis patients. Determining how we might intervene to ameliorate left ventricular hypertrophy in dialysis populations has become a research priority. Reducing sodium exposure through lower dialysate sodium may be a promising intervention in this regard. However there is clinical equipoise around this intervention because the benefit has not yet been demonstrated in a robust prospective clinical trial, and several observational studies have suggested sodium lowering interventions may be deleterious in some dialysis patients.

Methods/design

The Sodium Lowering in Dialysate (SoLID) study is funded by the Health Research Council of New Zealand. It is a multi-centre, prospective, randomised, single-blind (outcomes assessor), controlled parallel assignment 3-year clinical trial. The SoLID study is designed to study what impact low dialysate sodium has upon cardiovascular risk in dialysis patients. The study intends to enrol 118 home hemodialysis patients from 6 sites in New Zealand over 24 months and follow up each participant over 12 months. Key exclusion criteria are: patients who dialyse more frequently than 3.5 times per week, pre-dialysis serum sodium of <135 mM, and maintenance hemodiafiltration. In addition, some medical conditions, treatments or participation in other dialysis trials, which contraindicate the SoLID study intervention or confound its effects, will be exclusion criteria. The intervention and control groups will be dialysed using dialysate sodium 135 mM and 140 mM respectively, for 12 months. The primary outcome measure is left ventricular mass index, as measured by cardiac magnetic resonance imaging, after 12 months of intervention. Eleven or more secondary outcomes will be studied in an attempt to better understand the physiologic and clinical mechanisms by which lower dialysate sodium alters the primary end point.

Discussion

The SoLID study is designed to clarify the effect of low dialysate sodium upon the cardiovascular outcomes of dialysis patients. The study results will provide much needed information about the efficacy of a cost effective, economically sustainable solution to a condition which is curtailing the lives of so many dialysis patients.

Trial registration

Australian and New Zealand Clinical Trials Registry number: ACTRN12611000975998

【 授权许可】

   
2013 Dunlop et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

Figure 4.

【 参考文献 】

• [1]U.S. Renal Data System, USRDS 2012 Annual Data Report: Atlas of End-stage renal disease in the united states, national institutes of health, national institute of diabetes and digestive and kidney diseases. Bethesda, MD; 2012.
• [2]McDonald S: ANZDATA Registry Report, Australia and New Zealand Dialysis and Transplant Registry, Adelaide, South Australia. 2011.
• [3]Marshall MR, Hawley CM, Kerr PG, Polkinghorne KR, Marshall RJ, Agar JW, McDonald SP: Home hemodialysis and mortality risk in Australian and New Zealand populations. Am J Kidney Dis 2011, 58(5):782-793.
• [4]Zipes DP, Wellens HJ: Sudden cardiac death. Circulation 1998, 98(21):2334-2351.
• [5]Herzog CA, Mangrum JM, Passman R: Sudden cardiac death and dialysis patients. Semin Dial 2008, 21(4):300-307.
• [6]Herzog CA, Strief JW, Collins AJ, Gilbertson DT: Cause-specific mortality of dialysis patients after coronary revascularization: why don’t dialysis patients have better survival after coronary intervention? Nephrol Dial Transplant 2008, 23(8):2629-2633.
• [7]Nishimura M, Tokoro T, Nishida M, Hashimoto T, Kobayashi H, Yamazaki S, Imai R, Okino K, Iwamoto N, Takahashi H, et al.: Sympathetic overactivity and sudden cardiac death among hemodialysis patients with left ventricular hypertrophy. Int J Cardiol 2010, 142(1):80-86.
• [8]Zoccali C, Benedetto FA, Tripepi G, Mallamaci F: Cardiac consequences of hypertension in hemodialysis patients. Semin Dial 2004, 17(4):299-303.
• [9]Ritz E, Wanner C: The challenge of sudden death in dialysis patients. Clin J Am Soc Nephrol 2008, 3(3):920-929.
• [10]Amann K, Kronenberg G, Gehlen F, Wessels S, Orth S, Munter K, Ehmke H, Mall G, Ritz E: Cardiac remodelling in experimental renal failure–an immunohistochemical study. Nephrol Dial Transplant 1998, 13(8):1958-1966.
• [11]Amann K, Breitbach M, Ritz E, Mall G: Myocyte/capillary mismatch in the heart of uremic patients. J Am Soc Nephrol 1998, 9(6):1018-1022.
• [12]Glassock RJ, Pecoits-Filho R, Barberato SH: Left ventricular mass in chronic kidney disease and ESRD. Clin J Am Soc Nephrol 2009, 4(Suppl 1):S79-S91.
• [13]Diwan A, Wansapura J, Syed FM, Matkovich SJ, Lorenz JN, Dorn GW 2nd: Nix-mediated apoptosis links myocardial fibrosis, cardiac remodeling, and hypertrophy decompensation. Circulation 2008, 117(3):396-404.
• [14]Dorn GW 2nd: Apoptotic and non-apoptotic programmed cardiomyocyte death in ventricular remodelling. Cardiovasc Res 2009, 81(3):465-473.
• [15]Gross ML, Ritz E: Hypertrophy and fibrosis in the cardiomyopathy of uremia–beyond coronary heart disease. Semin Dial 2008, 21(4):308-318.
• [16]Nishida K, Kyoi S, Yamaguchi O, Sadoshima J, Otsu K: The role of autophagy in the heart. Cell Death Differ 2009, 16(1):31-38.
• [17]Silberberg JS, Barre PE, Prichard SS, Sniderman AD: Impact of left ventricular hypertrophy on survival in end-stage renal disease. Kidney Int 1989, 36(2):286-290.
• [18]Baigent C, Landray MJ, Reith C, Emberson J, Wheeler DC, Tomson C, Wanner C, Krane V, Cass A, Craig J, et al.: The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet 2011, 377(9784):2181-2192.
• [19]Fellstrom BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Gronhagen-Riska C, et al.: Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med 2009, 360(14):1395-1407.
• [20]Wanner C, Krane V, Marz W, Olschewski M, Mann JF, Ruf G, Ritz E, German Diabetes and Dialysis Study I: Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med 2005, 353(3):238-248.
• [21]Palmer SC, Craig JC, Navaneethan SD, Tonelli M, Pellegrini F, Strippoli GF: Benefits and harms of statin therapy for persons with chronic kidney disease: a systematic review and meta-analysis. Ann Intern Med 2012, 157(4):263-275.
• [22]Parker T 3rd, Hakim R, Nissenson AR, Steinman T, Glassock RJ: Dialysis at a crossroads: 50 years later. Clin J Am Soc Nephrol 2011, 6(2):457-461.
• [23]Parker TF 3rd, Glassock RJ, Steinman TI: Conclusions, consensus, and directions for the future. Clin J Am Soc Nephrol 2009, 4(Suppl 1):S139-S144.
• [24]Charra B, Calemard E, Ruffet M, Chazot C, Terrat J, Vanel T, Laurent G: Survival as an index of adequacy of dialysis. Kidney Int 1992, 41:1286-1291.
• [25]Charra B, Chazot C, Jean G, Hurot JM, Terrat JC, Vanel T, Lorriaux C, Vovan C: Role of sodium in dialysis. Minerva Urol Nefrol 2004, 56(3):205-213.
• [26]London GM, Pannier B, Guerin AP, Blacher J, Marchais SJ, Darne B, Metivier F, Adda H, Safar ME: Alterations of left ventricular hypertrophy in and survival of patients receiving hemodialysis: follow-up of an interventional study. J Am Soc Nephrol 2001, 12(12):2759-2767.
• [27]Ozkahya M, Ok E, Cirit M, Aydin S, Akcicek F, Basci A, Dorhout Mees EJ: Regression of left ventricular hypertrophy in haemodialysis patients by ultrafiltration and reduced salt intake without antihypertensive drugs. Nephrol Dial Transplant 1998, 13(6):1489-1493.
• [28]Ozkahya M, Toz H, Qzerkan F, Duman S, Ok E, Basci A, Mees E: Impact of volume control on left ventricular hypertrophy in dialysis patients. J Nephrol 2002, 15:655-660.
• [29]Koc Y, Unsal A, Kayabasi H, Oztekin E, Sakaci T, Ahbap E, Yilmaz M, Akgun AO: Impact of volume status on blood pressure and left ventricle structure in patients undergoing chronic hemodialysis. Ren Fail 2011, 33(4):377-381.
• [30]Li H, Wang SX: Improvement of hypertension and LVH in maintenance hemodialysis patients treated with sustained-release isosorbide mononitrate. J Nephrol 2011, 24(2):236-245.
• [31]Mominadam S, Ozkahya M, Kayikcioglu M, Toz H, Asci G, Duman S, Ergin P, Kirbiyik S, Ok E, Basci A: Interdialytic blood pressure obtained by ambulatory blood pressure measurement and left ventricular structure in hypertensive hemodialysis patients. Hemodial Int 2008, 12(3):322-327.
• [32]Inal S, Erten Y, Akbulu G, Onec K, Tek NA, Sahin G, Okyay GU, Sanlier N: Salt intake and hypervolemia in the development of hypertension in peritoneal dialysis patients. Adv Perit Dial 2012, 28:10-15.
• [33]Patel RK, Oliver S, Mark PB, Powell JR, McQuarrie EP, Traynor JP, Dargie HJ, Jardine AG: Determinants of left ventricular mass and hypertrophy in hemodialysis patients assessed by cardiac magnetic resonance imaging. Clin J Am Soc Nephrol 2009, 4(9):1477-1483.
• [34]Chertow GM, Levin NW, Beck GJ, Depner TA, Eggers PW, Gassman JJ, Gorodetskaya I, Greene T, James S, Larive B, et al.: In-center hemodialysis six times per week versus three times per week. N Engl J Med 2010, 363(24):2287-2300.
• [35]Culleton BF, Walsh M, Klarenbach SW, Mortis G, Scott-Douglas N, Quinn RR, Tonelli M, Donnelly S, Friedrich MG, Kumar A, et al.: Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life: a randomized controlled trial. JAMA 2007, 298(11):1291-1299.
• [36]Foley RN, Parfrey PS, Kent GM, Harnett JD, Murray DC, Barre PE: Serial change in echocardiographic parameters and cardiac failure in end-stage renal disease. J Am Soc Nephrol 2000, 11(5):912-916.
• [37]Zoccali C, Benedetto FA, Mallamaci F, Tripepi G, Giacone G, Stancanelli B, Cataliotti A, Malatino LS: Left ventricular mass monitoring in the follow-up of dialysis patients: prognostic value of left ventricular hypertrophy progression. Kidney Int 2004, 65(4):1492-1498.
• [38]Wilson J, Shah T, Nissenson AR: Role of sodium and volume in the pathogenesis of hypertension in hemodialysis. Semin Dial 2004, 17(4):260-264.
• [39]Wald R, Yan AT, Perl J, Jiang D, Donnelly MS, Leong-Poi H, McFarlane PA, Weinstein JJ, Goldstein MB: Regression of left ventricular mass following conversion from conventional hemodialysis to thrice weekly in-centre nocturnal hemodialysis. BMC Nephrol 2012, 13:3. BioMed Central Full Text
• [40]Chan CT, Floras JS, Miller JA, Richardson RM, Pierratos A: Regression of left ventricular hypertrophy after conversion to nocturnal hemodialysis. Kidney Int 2002, 61(6):2235-2239.
• [41]Marshall MR, Dunlop JL: Are dialysate sodium levels too high? Semin Dial 2012, 25(3):277-283.
• [42]Blankestijn PJ, Ligtenberg G: Volume-independent mechanisms of hypertension in hemodialysis patients: clinical implications. Semin Dial 2004, 17(4):265-269.
• [43]Friedman SM, McIndoe RA, Tanaka M: The relation of blood sodium concentration to blood pressure in the rat. J Hypertens 1990, 8(1):61-66.
• [44]He FJ, Fan S, Macgregor GA, Yaqoob MM: Plasma sodium and blood pressure in individuals on haemodialysis. J Hum Hypertens 2013, 27(2):85-89.
• [45]Tobian L, Hanlon S: High sodium chloride diets injure arteries and raise mortality without changing blood pressure. Hypertension 1990, 15(6 Pt 2):900-903.
• [46]Oberleithner H, Riethmuller C, Schillers H, MacGregor GA, de Wardener HE, Hausberg M: Plasma sodium stiffens vascular endothelium and reduces nitric oxide release. Proc Natl Acad Sci USA 2007, 104(41):16281-16286.
• [47]Levin A, Goldstein MB: The benefits and side effects of ramped hypertonic sodium dialysis. J Am Soc Nephrol 1996, 7(2):242-246.
• [48]Sang GL, Kovithavongs C, Ulan R, Kjellstrand CM: Sodium ramping in hemodialysis: a study of beneficial and adverse effects. Am J Kidney Dis 1997, 29(5):669-677.
• [49]Munoz Mendoza J, Sun S, Chertow GM, Moran J, Doss S, Schiller B: Dialysate sodium and sodium gradient in maintenance hemodialysis: a neglected sodium restriction approach? Nephrol Dial Transplant 2011, 26(4):1281-1287.
• [50]Martinez-Vea A, Garcia C, Gaya J, Rivera F, Oliver JA: Abnormalities of thirst regulation in patients with chronic renal failure on hemodialysis. Am J Nephrol 1992, 12(1–2):73-79.
• [51]Gumrukcuoglu HA, Ari E, Akyol A, Akdag S, Simsek H, Sahin M, Gunes Y, Tuncer M: Effects of lowering dialysate sodium on carotid artery atherosclerosis and endothelial dysfunction in maintenance hemodialysis patients. Int Urol Nephrol 2012, 44(6):1833-1839.
• [52]Daugirdas JT, Al-Kudsi RR, Ing TS, Norusis MJ: A double-blind evaluation of sodium gradient hemodialysis. Am J Nephrol 1985, 5(3):163-168.
• [53]Dominic SC, Ramachandran S, Somiah S, Mani K, Dominic SS: Quenching the thirst in dialysis patients. Nephron 1996, 73(4):597-600.
• [54]Wilkinson R, Barber SG, Robson V: Cramps, thirst and hypertension in hemodialysis patients – the influence of dialyzate sodium concentration. Clin Nephrol 1977, 7(3):101-105.
• [55]Zwiech R, Bruzda-Zwiech A: The dual blockade of the renin-angiotensin system in hemodialysis patients requires decreased dialysate sodium concentration. Int Urol Nephrol 2012.
• [56]Lambie SH, Taal MW, Fluck RJ, McIntyre CW: Online conductivity monitoring: validation and usefulness in a clinical trial of reduced dialysate conductivity. ASAIO J 2005, 51(1):70-76.
• [57]Davenport A: Audit of the effect of dialysate sodium concentration on inter-dialytic weight gains and blood pressure control in chronic haemodialysis patients. Nephron Clin Pract 2006, 104(3):c120-c125.
• [58]Fischbach M, Tarral E, Geisert J: Sequential hypertonic haemodialysis in children. Pediatr Nephrol 1988, 2(4):442-446.
• [59]Henrich WL, Woodard TD, McPhaul JJ Jr: The chronic efficacy and safety of high sodium dialysate: double-blind, crossover study. Am J Kidney Dis 1982, 2(3):349-353.
• [60]Boquin E, Parnell S, Grondin G, Wollard C, Leonard D, Michaels R, Levin NW: Crossover study of the effects of different dialysate sodium concentrations in large surface area, short-term dialysis. Proc Clin Dial Transplant Forum 1977, 7:48-52.
• [61]Tang HL, Wong SH, Chu KH, Lee W, Cheuk A, Tang CM, Kong IL, Fung KS, Tsang WK, Chan HW, et al.: Sodium ramping reduces hypotension and symptoms during haemodialysis. Hong Kong Med J 2006, 12(1):10-14.
• [62]Song JH, Lee SW, Suh CK, Kim MJ: Time-averaged concentration of dialysate sodium relates with sodium load and interdialytic weight gain during sodium-profiling hemodialysis. Am J Kidney Dis 2002, 40(2):291-301.
• [63]Shah A, Davenport A: Does a reduction in dialysate sodium improve blood pressure control in haemodialysis patients? Nephrology (Carlton) 2012, 17(4):358-363.
• [64]Sandhu E, Crawford C, Davenport A: Weight gains and increased blood pressure in outpatient hemodialysis patients due to change in acid dialysate concentrate supplier. Int J Artif Organs 2012, 35(9):642-647.
• [65]Munoz Mendoza J, Bayes LY, Sun S, Doss S, Schiller B: Effect of lowering dialysate sodium concentration on interdialytic weight gain and blood pressure in patients undergoing thrice-weekly in-center nocturnal hemodialysis: a quality improvement study. Am J Kidney Dis 2011, 58(6):956-963.
• [66]Manlucu J, Gallo K, Heidenheim PA, Lindsay RM: Lowering postdialysis plasma sodium (conductivity) to increase sodium removal in volume-expanded hemodialysis patients: a pilot study using a biofeedback software system. Am J Kidney Dis 2010, 56(1):69-76.
• [67]Levin NW, Zhu F, Keen M: Interdialytic weight gain and dry weight. Blood Purif 2001, 19(2):217-221.
• [68]Ireland R: Dialysis: Does reducing dialysate sodium level lower blood pressure? Nat Rev Nephrol 2012, 8(4):192.
• [69]Del Giudice A, Cicchella A, Di Giorgio G, Piemontese M, Prencipe M, Fontana A, Copetti M, Pellegrini F, Aucella F: [Prevalence and control of hypertension in chronic hemodialysis patients: results of a single-centre clinical audit]. G Ital Nefrol 2012, 29(2):230-237.
• [70]Barre PE, Brunelle G, Gascon-Barre M: A randomized double blind trial of dialysate sodiums of 145 mEq/L, 150 mEq/L, and 155 mEq/L. ASAIO Trans 1988, 34(3):338-341.
• [71]Arramreddy R, Sun SJ, Munoz Mendoza J, Chertow GM, Schiller B: Individualized reduction in dialysate sodium in conventional in-center hemodialysis. Hemodial Int 2012, 16(4):473-480.
• [72]Hecking M, Karaboyas A, Saran R, Sen A, Inaba M, Rayner H, Horl WH, Pisoni RL, Robinson BM, Sunder-Plassmann G, et al.: Dialysate sodium concentration and the association with interdialytic weight gain, hospitalization, and mortality. Clin J Am Soc Nephrol 2012, 7(1):92-100.
• [73]Hecking M, Kainz A, Horl WH, Herkner H, Sunder-Plassmann G: Sodium setpoint and sodium gradient: influence on plasma sodium change and weight gain. Am J Nephrol 2011, 33(1):39-48.
• [74]Hamzi AM, Asseraji M, Hassani K, Alayoud A, Abdellali B, Zajjari Y, Montacer DB, Akhmouch I, Benyahia M, Oualim Z: Applying sodium profile with or without ultrafiltration profile failed to show beneficial effects on the incidence of intradialytic hypotension in susceptible hemodilaysis patients. Arab J Nephrol Transplant 2012, 5(3):129-134.
• [75]Davenport A, Cox C, Thuraisingham R: The importance of dialysate sodium concentration in determining interdialytic weight gains in chronic hemodialysis patients: the PanThames Renal Audit. Int J Artif Organs 2008, 31(5):411-417.
• [76]Ebel H, Laage C, Keuchel M, Dittmar A, Saure B, Ehlenz K, Lange H: Impact of profile haemodialysis on intra-/extracellular fluid shifts and the release of vasoactive hormones in elderly patients on regular dialysis treatment. Nephron 1997, 75(3):264-271.
• [77]Ogden DA: A double blind crossover comparison of high and low sodium dialysis. Proc Clin Dial Transplant Forum 1978, 8:157-165.
• [78]Oliver MJ, Edwards LJ, Churchill DN: Impact of sodium and ultrafiltration profiling on hemodialysis-related symptoms. J Am Soc Nephrol 2001, 12(1):151-156.
• [79]Kimura G, Gotch FA: Serum sodium concentration and body fluid distribution during interdialysis: importance of sodium to fluid intake ratio in hemodialysis patients. Int J Artif Organs 1984, 7(6):331-336.
• [80]Van Stone JC, Bauer J, Carey J: The effect of dialysate sodium concentration on body fluid compartment volume, plasma renin activity and plasma aldosterone concentration in chronic hemodialysis patients. Am J Kidney Dis 1982, 2(1):58-64.
• [81]Krautzig S, Janssen U, Koch K, Granolleras C, Shaldon S: Dietary salt restriction and reduction of dialysate sodium to control hypertension in maintenance haemodialysis patients. Nephrol Dial Transplant 1998, 13:552-553.
• [82]Krautzig S, Kielstein J, Granolleras C, Shaldon S, Lonnemann G, Koch K: Control of hypertension in HD pateints by reduction of dialysate sodium and low salt diet. J Am Soc Nephrol 1997, 8:243A. Abstr
• [83]Farmer CKT, Donohoe P, Dallyn P, Cox J, Kingswood JC, Goldsmith DJA: Low-sodium haemodialysis without fluid removal improves blood pressure control in chronic haemodialysis patients. Nephrology (Carlton) 2000, 5(4):237-241.
• [84]Parsons D, Yuill E, Llapitan M, Harris D: Sodium modelling and profiled ultrafiltration in conventional haemodialysis. Nephrology (Carlton) 1997, 3:177-182.
• [85]Dumler F, Grondin G, Levin NW: Sequential high/low sodium hemodialysis: an alternative to ultrafiltration. ASAIO Trans 1979, 25:351-353.
• [86]Jenson BM, Dobbe SA, Squillace DP, McCarthy JT: Clinical benefits of high and variable sodium concentration dialysate in hemodialysis patients. ANNA J 1994, 21(2):115-120. discussion 121
• [87]Sadowski RH, Allred EN, Jabs K: Sodium modeling ameliorates intradialytic and interdialytic symptoms in young hemodialysis patients. J Am Soc Nephrol 1993, 4(5):1192-1198.
• [88]Kooman JP, Hendriks EJ, van Den Sande FM, Leumissen KM: Dialysate sodium concentration and blood pressure control in haemodialysis patients. Nephrol Dial Transplant 2000, 15(4):554.
• [89]Thein H, Haloob I, Marshall MR: Associations of a facility level decrease in dialysate sodium concentration with blood pressure and interdialytic weight gain. Nephrol Dial Transplant 2007, 22(9):2630-2639.
• [90]Sayarlioglu H, Erkoc R, Tuncer M, Soyoral Y, Esen R, Gumrukcuoglu HA, Dogan E, Sayarlioglu M: Effects of low sodium dialysate in chronic hemodialysis patients: an echocardiographic study. Ren Fail 2007, 29(2):143-146.
• [91]Aybal Kutlugun A, Erdem Y, Okutucu S, Yorgun H, Atalar E, Arici M: Effects of lowering dialysate sodium on flow-mediated dilatation in patients with chronic kidney disease. Nephrol Dial Transplant 2011, 26(11):3678-3682.
• [92]Hecking M, Karaboyas A, Saran R, Sen A, Horl WH, Pisoni RL, Robinson BM, Sunder-Plassmann G, Port FK: Predialysis serum sodium level, dialysate sodium, and mortality in maintenance hemodialysis patients: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2012, 59(2):238-248.
• [93]Mc Causland FR, Brunelli SM, Waikar SS: Dialysate sodium, serum sodium and mortality in maintenance hemodialysis. Nephrol Dial Transplant 2012, 27(4):1613-1618.
• [94]Breidthardt T, McIntyre CW: Dialysis-induced myocardial stunning: the other side of the cardiorenal syndrome. Rev Cardiovasc Med 2011, 12(1):13-20.
• [95]Burton JO, Jefferies HJ, Selby NM, McIntyre CW: Hemodialysis-induced cardiac injury: determinants and associated outcomes. Clin J Am Soc Nephrol 2009, 4(5):914-920.
• [96]Burton JO, Jefferies HJ, Selby NM, McIntyre CW: Hemodialysis-induced repetitive myocardial injury results in global and segmental reduction in systolic cardiac function. Clin J Am Soc Nephrol 2009, 4(12):1925-1931.
• [97]Burton JO, Korsheed S, Grundy BJ, McIntyre CW: Hemodialysis-induced left ventricular dysfunction is associated with an increase in ventricular arrhythmias. Ren Fail 2008, 30(7):701-709.
• [98]McIntyre CW: Recurrent circulatory stress: the dark side of dialysis. Semin Dial 2010, 23(5):449-451.
• [99]Curatola G, Bolignano D, Rastelli S, Caridi G, Tripepi R, Tripepi G, Politi R, Catalano F, Delfino D, Ciccarelli M, et al.: Ultrafiltration intensification in hemodialysis patients improves hypertension but increases AV fistula complications and cardiovascular events. J Nephrol 2011, 24(4):465-473.
• [100]de Paula FM, Peixoto AJ, Pinto LV, Dorigo D, Patricio PJ, Santos SF: Clinical consequences of an individualized dialysate sodium prescription in hemodialysis patients. Kidney Int 2004, 66(3):1232-1238.
• [101]Flanigan MJ: Role of sodium in hemodialysis. Kidney Int Suppl 2000, 76:S72-S78.
• [102]Gotch FA, Lam MA, Prowitt M, Keen M: Preliminary clinical results with sodium-volume modeling of hemodialysis therapy. Proc Clin Dial Transplant Forum 1980, 10:12-17.
• [103]Lopot F, Blaha J, Valek A: An equation for calculating postdialysis plasma sodium. Int J Artif Organs 1992, 15(6):354-357.
• [104]Zerbe RL, Miller JZ, Robertson GL: The reproducibility and heritability of individual differences in osmoregulatory function in normal human subjects. J Lab Clin Med 1991, 117(1):51-59.
• [105]Raimann JG, Thijssen S, Usvyat LA, Levin NW, Kotanko P: Sodium alignment in clinical practice–implementation and implications. Semin Dial 2011, 24(5):587-592.
• [106]Acchiardo SR, Hayden AJ: Is Na + modeling necessary in high flux dialysis? ASAIO Trans 1991, 37(3):M135-M137.
• [107]Bonomini V, Coli L, Scolari MP: Profiling dialysis: a new approach to dialysis intolerance. Nephron 1997, 75(1):1-6.
• [108]Titze J: Water-free Na + retention: interaction with hypertension and tissue hydration. Blood Purif 2008, 26(1):95-99.
• [109]Titze J: Water-free sodium accumulation. Semin Dial 2009, 22(3):253-255.
• [110]Titze J, Maillet A, Lang R, Gunga HC, Johannes B, Gauquelin-Koch G, Kihm E, Larina I, Gharib C, Kirsch KA: Long-term sodium balance in humans in a terrestrial space station simulation study. Am J Kidney Dis 2002, 40(3):508-516.
• [111]Titze J, Ritz E: Salt and its effect on blood pressure and target organ damage: new pieces in an old puzzle. J Nephrol 2009, 22(2):177-189.
• [112]Nigwekar S, Wenger J, Thadhani R, Bhan I: Low serum sodium, bone mineral disease and mortality in incident chronic hemodialysis patients. J Am Soc Nephrol 2011, 22:58A.
• [113]Waikar SS, Curhan GC, Brunelli SM: Mortality associated with low serum sodium concentration in maintenance hemodialysis. Am J Med 2011, 124(1):77-84.
• [114]Kovesdy CP, Lott EH, Lu JL, Malakauskas SM, Ma JZ, Molnar MZ, Kalantar-Zadeh K: Hyponatremia, hypernatremia, and mortality in patients with chronic kidney disease with and without congestive heart failure. Circulation 2012, 125(5):677-684.
• [115]Alderman MH: The Cochrane review of sodium and health. Am J Hypertens 2011, 24(8):854-856.
• [116]Taylor RS, Ashton KE, Moxham T, Hooper L, Ebrahim S: Reduced dietary salt for the prevention of cardiovascular disease. Cochrane Database Syst Rev 2011., 7CD009217
• [117]Taylor RS, Ashton KE, Moxham T, Hooper L, Ebrahim S: Reduced dietary salt for the prevention of cardiovascular disease: a meta-analysis of randomized controlled trials (Cochrane review). Am J Hypertens 2011, 24(8):843-853.
• [118]Garg R, Williams GH, Hurwitz S, Brown NJ, Hopkins PN, Adler GK: Low-salt diet increases insulin resistance in healthy subjects. Metabolism 2011, 60(7):965-968.
• [119]Grassi G, Dell’Oro R, Seravalle G, Foglia G, Trevano FQ, Mancia G: Short- and long-term neuroadrenergic effects of moderate dietary sodium restriction in essential hypertension. Circulation 2002, 106(15):1957-1961.
• [120]Graudal NA, Galloe AM, Garred P: Effects of sodium restriction on blood pressure, renin, aldosterone, catecholamines, cholesterols, and triglyceride: a meta-analysis. JAMA 1998, 279(17):1383-1391.
• [121]Petrie JR, Morris AD, Minamisawa K, Hilditch TE, Elliott HL, Small M, McConnell J: Dietary sodium restriction impairs insulin sensitivity in noninsulin-dependent diabetes mellitus. J Clin Endocrinol Metab 1998, 83(5):1552-1557.
• [122]Covic A, Mardare NG, Ardeleanu S, Prisada O, Gusbeth-Tatomir P, Goldsmith DJ: Serial echocardiographic changes in patients on hemodialysis: an evaluation of guideline implementation. J Nephrol 2006, 19(6):783-793.
• [123]Westlie L, Umen A, Nestrud S, Kjellstrand CM: Mortality, morbidity, and life satisfaction in the very old dialysis patient. Trans Am Soc Artif Intern Organs 1984, 30:21-30.
• [124]McGregor DO, Buttimore AL, Nicholls MG, Lynn KL: Ambulatory blood pressure monitoring in patients receiving long, slow home haemodialysis. Nephrol Dial Transplant 1999, 14(11):2676-2679.
• [125]Petitclerc T, Jacobs C: Dialysis sodium concentration: what is optimal and can it be individualized? Nephrol Dial Transplant 1995, 10(5):596-599.
• [126]Di Filippo S, Corti M, Andrulli S, Manzoni C, Locatelli F: Determining the adequacy of sodium balance in hemodialysis using a kinetic model. Blood Purif 1996, 14(6):431-436.
• [127]Di Filippo S, Corti M, Andrulli S, Pontoriero G, Manzoni C, Locatelli F: Optimization of sodium removal in paired filtration dialysis by single pool sodium and conductivity kinetic models. Blood Purif 1997, 15(1):34-44.
• [128]Murisasco A, France G, Leblond G, Durand C, el Mehdi M, Crevat A, Elsen R, Boobes Y, Baz M: Sequential sodium therapy allows correction of sodium-volume balance and reduces morbidity. Clin Nephrol 1985, 24(4):201-208.
• [129]Murisasco A, Leblond G, Elsen R, Stroumza P, Durand C, Jeanningros E, Crevat A, Reynier JP: Equilibration of body water distribution and Na + balance during hemodialysis (HD) with an ion specific electrode feedback system and integrated computer. Trans Am Soc Artif Intern Organs 1984, 30:254-259.
• [130]Locatelli F, Di Filippo S, Manzoni C, Corti M, Andrulli S, Pontoriero G: Monitoring sodium removal and delivered dialysis by conductivity. Int J Artif Organs 1995, 18(11):716-721.
• [131]Bosetto A, Bene B, Petitclerc T: Sodium management in dialysis by conductivity. Adv Ren Replace Ther 1999, 6(3):243-254.
• [132]Ash S, Campbell K, MacLaughlin H, McCoy E, Chan M, Anderson K, Corke K, Dumont R, Lloyd L, Meade A, et al.: Evidence based practice guidelines for the nutritional management of chronic kidney disease. Nutr Diet 2006, 63:S33-S45.
• [133]Young AA, Cowan BR, Thrupp SF, Hedley WJ, Dell’Italia LJ: Left ventricular mass and volume: fast calculation with guide-point modeling on MR images. Radiology 2000, 216(2):597-602.
• [134]Wang AY, Wai-Kei Lam C: The diagnostic utility of cardiac biomarkers in dialysis patients. Semin Dial 2012, 25(4):388-396.
• [135]Dhar S, Pressman GS, Subramanian S, Kaul S, Gollamudi S, Bloom EJ, Figueredo VM: Natriuretic peptides and heart failure in the patient with chronic kidney disease: a review of current evidence. Postgrad Med J 2009, 85(1004):299-302.
• [136]Choi SY, Lee JE, Jang EH, Kim MO, Baek H, Ki CS, Park SW, Kim DJ, Huh WS, Oh HY, et al.: Association between changes in N-terminal pro-brain natriuretic peptide levels and changes in left ventricular mass index in stable hemodialysis patients. Nephron Clin Pract 2008, 110(2):c93-c100.
• [137]Roberts MA, Srivastava PM, Macmillan N, Hare DL, Ratnaike S, Sikaris K, Ierino FL: B-type natriuretic peptides strongly predict mortality in patients who are treated with long-term dialysis. Clin J Am Soc Nephrol 2008, 3(4):1057-1065.
• [138]Wang AY, Lam CW, Yu CM, Wang M, Chan IH, Zhang Y, Lui SF, Sanderson JE: N-terminal pro-brain natriuretic peptide: an independent risk predictor of cardiovascular congestion, mortality, and adverse cardiovascular outcomes in chronic peritoneal dialysis patients. J Am Soc Nephrol 2007, 18(1):321-330.
• [139]Lee JA, Kim DH, Yoo SJ, Oh DJ, Yu SH, Kang ET: Association between serum n-terminal pro-brain natriuretic peptide concentration and left ventricular dysfunction and extracellular water in continuous ambulatory peritoneal dialysis patients. Perit Dial Int 2006, 26(3):360-365.
• [140]Racek J, Kralova H, Trefil L, Rajdl D, Eiselt J: Brain natriuretic peptide and N-terminal proBNP in chronic haemodialysis patients. Nephron Clin Pract 2006, 103(4):c162-c172.
• [141]Zoccali C, Mallamaci F: Urotensin II: a cardiovascular and renal update. Curr Opin Nephrol Hypertens 2008, 17(2):199-204.
• [142]Zoccali C, Mallamaci F, Benedetto FA, Tripepi G, Pizzini P, Cutrupi S, Malatino L: Urotensin II and cardiomyopathy in end-stage renal disease. Hypertension 2008, 51(2):326-333.
• [143]Ravani P, Tripepi G, Pecchini P, Mallamaci F, Malberti F, Zoccali C: Urotensin II is an inverse predictor of death and fatal cardiovascular events in chronic kidney disease. Kidney Int 2008, 73(1):95-101.
• [144]Mallamaci F, Cutrupi S, Pizzini P, Tripepi G, Zoccali C: Urotensin II and biomarkers of endothelial activation and atherosclerosis in end-stage renal disease. Am J Hypertens 2006, 19(5):505-510.
• [145]Zoccali C, Mallamaci F, Tripepi G, Cutrupi S, Pizzini P, Malatino L: Urotensin II is an inverse predictor of incident cardiovascular events in end-stage renal disease. Kidney Int 2006, 69(7):1253-1258.
• [146]Chen YH, Yandle TG, Richards AM, Palmer SC: Urotensin II immunoreactivity in the human circulation: evidence for widespread tissue release. Clin Chem 2009, 55(11):2040-2048.
• [147]Dou Y, Zhu F, Kotanko P: Assessment of extracellular fluid volume and fluid status in hemodialysis patients: current status and technical advances. Semin Dial 2012, 25(4):377-387.
• [148]Davenport A: Negative dialysate to sodium gradient does not lead to intracellular volume expansion post hemodialysis. Int J Artif Organs 2010, 33(10):700-705.
• [149]Kotanko P, Levin NW, Zhu F: Current state of bioimpedance technologies in dialysis. Nephrol Dial Transplant 2008, 23(3):808-812.
• [150]Agarwal R: The controversies of diagnosing and treating hypertension among hemodialysis patients. Semin Dial 2012, 25(4):370-376.
• [151]Agarwal R, Metiku T, Tegegne GG, Light RP, Bunaye Z, Bekele DM, Kelley K: Diagnosing hypertension by intradialytic blood pressure recordings. Clin J Am Soc Nephrol 2008, 3(5):1364-1372.
• [152]Thompson AM, Pickering TG: The role of ambulatory blood pressure monitoring in chronic and end-stage renal disease. Kidney Int 2006, 70(6):1000-1007.
• [153]Pickering TG, Shimbo D, Haas D: Ambulatory blood-pressure monitoring. N Engl J Med 2006, 354(22):2368-2374.
• [154]Agarwal R, Brim NJ, Mahenthiran J, Andersen MJ, Saha C: Out-of-hemodialysis-unit blood pressure is a superior determinant of left ventricular hypertrophy. Hypertension 2006, 47(1):62-68.
• [155]Agarwal R: Blood pressure and mortality among hemodialysis patients. Hypertension 2010, 55(3):762-768.
• [156]O’Brien E, Asmar R, Beilin L, Imai Y, Mancia G, Mengden T, Myers M, Padfield P, Palatini P, Parati G, et al.: Practice guidelines of the European Society of Hypertension for clinic, ambulatory and self blood pressure measurement. J Hypertens 2005, 23(4):697-701.
• [157]Agarwal R, Andersen MJ, Bishu K, Saha C: Home blood pressure monitoring improves the diagnosis of hypertension in hemodialysis patients. Kidney Int 2006, 69(5):900-906.
• [158]Alborzi P, Patel N, Agarwal R: Home blood pressures are of greater prognostic value than hemodialysis unit recordings. Clin J Am Soc Nephrol 2007, 2(6):1228-1234.
• [159]Wan SH, Hart M, Hajjar I: A novel measurement index for antihypertensive medication burden and its use. Hypertension 2009, 54(5):e135-e136.
• [160]Thomson WM: Measuring change in dry-mouth symptoms over time using the Xerostomia Inventory. Gerodontology 2007, 24(1):30-35.
• [161]Thomson WM, Chalmers JM, Spencer AJ, Williams SM: The Xerostomia Inventory: a multi-item approach to measuring dry mouth. Community Dent Health 1999, 16(1):12-17.
• [162]Thomson WM, van der Putten GJ, de Baat C, Ikebe K, Matsuda K, Enoki K, Hopcraft MS, Ling GY: Shortening the xerostomia inventory. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2011, 112(3):322-327.
• [163]Bots CP, Brand HS, Veerman EC, Valentijn-Benz M, Van Amerongen BM, Valentijn RM, Vos PF, Bijlsma JA, Bezemer PD, Te Wee PM, et al.: Interdialytic weight gain in patients on hemodialysis is associated with dry mouth and thirst. Kidney Int 2004, 66(4):1662-1668.
• [164]K/DOQI: Clinical practice guidelines for cardiovascular disease in dialysis patients. Am J Kidney Dis 2005, 45:16-153.
• [165]Tomlinson LA: Methods for assessing arterial stiffness: technical considerations. Curr Opin Nephrol Hypertens 2012, 21(6):655-660.
• [166]Locatelli F, Di Filippo G, Manzoni C: Hemodialysis fliud composition. In Replacement of renal function by dialysis. 5th edition. Edited by Hörl WH, Koch KM, Lindsay RM, Ronco C, Winchester JF. Dordrecht, The Netherlands: Springer; 2004:585-587.
• [167]Manns B, Johnson JA, Taub K, Mortis G, Ghali WA, Donaldson C: Quality of life in patients treated with hemodialysis or peritoneal dialysis: what are the important determinants? Clin Nephrol 2003, 60(5):341-351.
• [168]Manns BJ, Walsh MW, Culleton BF, Hemmelgarn B, Tonelli M, Schorr M, Klarenbach S, Alberta Kidney Disease N: Nocturnal hemodialysis does not improve overall measures of quality of life compared to conventional hemodialysis. Kidney Int 2009, 75(5):542-549.
• [169]Wyld M, Morton RL, Hayen A, Howard K, Webster AC: A systematic review and meta-analysis of utility-based quality of life in chronic kidney disease treatments. PLoS Med 2012, 9(9):e1001307.
• [170]Rao S, Carter WB, Mapes DL, Kallich JD, Kamberg CJ, Spritzer KL, Hays RD: Development of subscales from the symptoms/problems and effects of kidney disease scales of the kidney disease quality of life instrument. Clin Ther 2000, 22(9):1099-1111.
• [171]Kallich JD, Hays RD, Mapes DL, Coons SJ, Carter WB: The RAND kidney disease and quality of life instrument. Nephrol News Issues 1995, 9(9):29-36.
• [172]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(5):329-338.
• [173]Dolan P: Modeling valuations for EuroQol health states. Med Care 1997, 35(11):1095-1108.
• [174]Patel RK, Jardine AG, Mark PB, Cunningham AF, Steedman T, Powell JR, McQuarrie EP, Stevens KK, Dargie HJ: Association of left atrial volume with mortality among ESRD patients with left ventricular hypertrophy referred for kidney transplantation. Am J Kidney Dis 2010, 55(6):1088-1096.
• [175]Mark PB, Patel RK, Jardine AG: Are we overestimating left ventricular abnormalities in end-stage renal disease? Nephrol Dial Transplant 2007, 22(7):1815-1819.
• [176]Pan W: Akaike’s information criterion in generalized estimating equations. Biometrics 2001, 57(1):120-125.
• [177]Covic A, Goldsmith DJ, Georgescu G, Venning MC, Ackrill P: Echocardiographic findings in long-term, long-hour hemodialysis patients. Clin Nephrol 1996, 45(2):104-110.
• [178]Huting J, Kramer W, Charra B, Laurent G, Wizemann V, Schutterle G: Asymmetric septal hypertrophy and left atrial dilatation in patients with end-stage renal disease on long-term hemodialysis. Clin Nephrol 1989, 32(6):276-283.