Trials | |
Blood volume-monitored regulation of ultrafiltration in fluid-overloaded hemodialysis patients: study protocol for a randomized controlled trial | |
Marcus D Säemann4  Gere Sunder-Plassmann4  Walter H Hörl4  Renate Klauser-Braun2  Gernot Paul2  Manfred Eigner5  Katharina Lorenz-Turnheim5  Isabella Exner5  Peter Josten1  Hans-Dietrich Polaschegg3  Thomas Weichhart4  Michael Haidinger4  Johannes Werzowa4  Thomas Reiter4  Wolfgang Winnicki4  Marlies Antlanger4  Manfred Hecking4  | |
[1] Nikkiso Europe GmbH, Beneckealle 30, Hanover, 30419, Germany;Sozialmedizinisches Zentrum Ost, Donauspital, 3rd Medical Department, Dialysis, Langobardenstrasse 122, Vienna, 1220, Austria;Malerweg 12, Köstenberg, 9231, Austria;Department of Internal Medicine III, Nephrology and Dialysis, Medical University of Vienna, Währinger Gürtel 18-20, Vienna 1090, Austria;Sozialmedizinisches Zentrum Süd, Kaiser-Franz-Josef Spital, 1st Medical Department, Dialysis, Kundratstrasse 3, Vienna, 1100, Austria | |
关键词: Randomized controlled trials.; Multicenter study; Blood volume; Fluid shifts; Renal dialysis; Ultrafiltration; Dialysis; | |
Others : 1095547 DOI : 10.1186/1745-6215-13-79 |
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received in 2012-01-21, accepted in 2012-06-08, 发布年份 2012 | |
【 摘 要 】
Background
Data generated with the body composition monitor (BCM, Fresenius) show, based on bioimpedance technology, that chronic fluid overload in hemodialysis patients is associated with poor survival. However, removing excess fluid by lowering dry weight can be accompanied by intradialytic and postdialytic complications. Here, we aim at testing the hypothesis that, in comparison to conventional hemodialysis, blood volume-monitored regulation of ultrafiltration and dialysate conductivity (UCR) and/or regulation of ultrafiltration and temperature (UTR) will decrease complications when ultrafiltration volumes are systematically increased in fluid-overloaded hemodialysis patients.
Methods/design
BCM measurements yield results on fluid overload (in liters), relative to extracellular water (ECW). In this prospective, multicenter, triple-arm, parallel-group, crossover, randomized, controlled clinical trial, we use BCM measurements, routinely introduced in our three maintenance hemodialysis centers shortly prior to the start of the study, to recruit sixty hemodialysis patients with fluid overload (defined as ≥15% ECW). Patients are randomized 1:1:1 into UCR, UTR and conventional hemodialysis groups. BCM-determined, ‘final’ dry weight is set to normohydration weight −7% of ECW postdialysis, and reached by reducing the previous dry weight, in steps of 0.1 kg per 10 kg body weight, during 12 hemodialysis sessions (one study phase). In case of intradialytic complications, dry weight reduction is decreased, according to a prespecified algorithm. A comparison of intra- and post-dialytic complications among study groups constitutes the primary endpoint. In addition, we will assess relative weight reduction, changes in residual renal function, quality of life measures, and predialysis levels of various laboratory parameters including C-reactive protein, troponin T, and N-terminal pro-B-type natriuretic peptide, before and after the first study phase (secondary outcome parameters).
Discussion
Patients are not requested to revert to their initial degree of fluid overload after each study phase. Therefore, the crossover design of the present study merely serves the purpose of secondary endpoint evaluation, for example to determine patient choice of treatment modality. Previous studies on blood volume monitoring have yielded inconsistent results. Since we include only patients with BCM-determined fluid overload, we expect a benefit for all study participants, due to strict fluid management, which decreases the mortality risk of hemodialysis patients.
Trial registration
ClinicalTrials.gov, NCT01416753
【 授权许可】
2012 Hecking et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
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20150130185513566.pdf | 479KB | download | |
Figure 2. | 65KB | Image | download |
Figure 1. | 25KB | Image | download |
【 图 表 】
Figure 1.
Figure 2.
【 参考文献 】
- [1]Scribner BH, Buri R, Caner JE, Hegstrom R, Burnell JM: The treatment of chronic uremia by means of intermittent hemodialysis: a preliminary report. Trans Am Soc Artif Intern Organs 1960, 6:114-122.
- [2]Franz M, Pohanka E, Tribl B, Woloszczuk W, Horl WH: Living on chronic hemodialysis between dryness and fluid overload. Kidney Int Suppl 1997, 59:S39-42.
- [3]Wabel P, Chamney P, Moissl U, Jirka T: Importance of whole-body bioimpedance spectroscopy for the management of fluid balance. Blood Purif 2009, 27:75-80.
- [4]Moissl UM, Wabel P, Chamney PW, Bosaeus I, Levin NW, Bosy-Westphal A, Korth O, Muller MJ, Ellegard L, Malmros V, Kaitwatcharachai C, Kuhlmann MK, Zhu F, Fuller NJ: Body fluid volume determination via body composition spectroscopy in health and disease. Physiol Meas 2006, 27:921-933.
- [5]Moissl U, Bosaeus I, Lemmey A, Hovgesen S, Wabel P, Chamney PW, Bosy-Westphal A, Korth O, Mueller MJ, Renders L, Ellegard L, Malmros V, Fuller NJ: Validation of a 3 C model for determination of body fat mass. J Am Soc Nephrol 2007, 18:257A.
- [6]Moissl U, Wabel P, Chamney PW, Renders L, Bosy-Westphal A, Korth O, Müller MJ: Validation of a bioimpedance spectroscopy method for the assessment of fat free mass. NDT plus 2008, 1(suppl 2):ii215.
- [7]Passauer JMH, Schleser A, Leicht J, Pucalka K: Evaluation of clinical dry weight assessment in haemodialysis patients by bioimpedance-spectroscopy. J Am Soc Nephrol 2007, 18:256A.
- [8]Wizemann V, Wabel P, Chamney P, Zaluska W, Moissl U, Rode C, Malecka-Masalska T, Marcelli D: The mortality risk of overhydration in haemodialysis patients. Nephrol Dial Transplant 2009, 24:1574-1579.
- [9]Kalantar-Zadeh K, Regidor DL, Kovesdy CP, Van Wyck D, Bunnapradist S, Horwich TB, Fonarow GC: Fluid retention is associated with cardiovascular mortality in patients undergoing long-term hemodialysis. Circulation 2009, 119:671-679.
- [10]Saran R, Bragg-Gresham JL, Rayner HC, Goodkin DA, Keen ML, Van Dijk PC, Kurokawa K, Piera L, Saito A, Fukuhara S, Young EW, Held PJ, Port FK: Nonadherence in hemodialysis: associations with mortality, hospitalization, and practice patterns in the DOPPS. Kidney Int 2003, 64:254-262.
- [11]Agarwal R, Alborzi P, Satyan S, Light RP: Dry-weight reduction in hypertensive hemodialysis patients (DRIP): a randomized, controlled trial. Hypertension 2009, 53:500-507.
- [12]Steuer RR, Harris DH, Weiss RL, Biddulph MC, Conis JM: Evaluation of a noninvasive hematocrit monitor: a new technology. Am Clin Lab 1991, 10:20-22.
- [13]Mancini E, Santoro A, Spongano M, Paolini F, Rossi M, Zucchelli P: Continuous on-line optical absorbance recording of blood volume changes during hemodialysis. Artif Organs 1993, 17:691-694.
- [14]Paolini F, Mancini E, Bosetto A, Santoro A: Hemoscan: a dialysis machine-integrated blood volume monitor. Int J Artif Organs 1995, 18:487-494.
- [15]Steuer RHD, Conis J: A new optical technique for monitoring hematocrit and circulating blood volume: its application in renal dialysis. Dial Transplant 1993, 22:260-265.
- [16]Dasselaar JJ, Huisman RM, de Jong PE, Franssen CF: Measurement of relative blood volume changes during haemodialysis: merits and limitations. Nephrol Dial Transplant 2005, 20:2043-2049.
- [17]Johner C, Chamney PW, Schneditz D, Kramer M: Evaluation of an ultrasonic blood volume monitor. Nephrol Dial Transplant 1998, 13:2098-2103.
- [18]Schneditz D, Pogglitsch H, Horina J, Binswanger U: A blood protein monitor for the continuous measurement of blood volume changes during hemodialysis. Kidney Int 1990, 38:342-346.
- [19]Steuer RR, Leypoldt JK, Cheung AK, Senekjian HO, Conis JM: Reducing symptoms during hemodialysis by continuously monitoring the hematocrit. Am J Kidney Dis 1996, 27:525-532.
- [20]Reddan DN, Szczech LA, Hasselblad V, Lowrie EG, Lindsay RM, Himmelfarb J, Toto RD, Stivelman J, Winchester JF, Zillman LA, Califf RM, Owen WF: Intradialytic blood volume monitoring in ambulatory hemodialysis patients: a randomized trial. J Am Soc Nephrol 2005, 16:2162-2169.
- [21]Andrulli S, Colzani S, Mascia F, Lucchi L, Stipo L, Bigi MC, Crepaldi M, Redaelli B, Albertazzi A, Locatelli F: The role of blood volume reduction in the genesis of intradialytic hypotension. Am J Kidney Dis 2002, 40:1244-1254.
- [22]Barth C, Boer W, Garzoni D, Kuenzi T, Ries W, Schaefer R, Schneditz D, Tsobanelis T, van der Sande F, Wojke R, Schilling H, Passlick-Deetjen J: Characteristics of hypotension-prone haemodialysis patients: is there a critical relative blood volume? Nephrol Dial Transplant 2003, 18:1353-1360.
- [23]Tonelli M, Astephen P, Andreou P, Beed S, Lundrigan P, Jindal K: Blood volume monitoring in intermittent hemodialysis for acute renal failure. Kidney Int 2002, 62:1075-1080.
- [24]Mitra S, Chamney P, Greenwood R, Farrington K: Linear decay of relative blood volume during ultrafiltration predicts hemodynamic instability. Am J Kidney Dis 2002, 40:556-565.
- [25]Krepel HP, Nette RW, Akcahuseyin E, Weimar W, Zietse R: Variability of relative blood volume during haemodialysis. Nephrol Dial Transplant 2000, 15:673-679.
- [26]Boer W, Cremaschi L, et al.: Less intradialytic complications with blood volume control. Nephrol Dial Transplant 2002, 17(Suppl 1):127-128.
- [27]Damasiewicz MJ, Polkinghorne KR: Intra-dialytic hypotension and blood volume and blood temperature monitoring. Nephrology (Carlton) 2011, 16:13-18.
- [28]Gabrielli D, Krystal B, Katzarski K, Youssef M, Hachache T, Lopot F, Lasseur C, Gunne T, Draganov B, Wojke R, Gauly A: Improved intradialytic stability during haemodialysis with blood volume-controlled ultrafiltration. J Nephrol 2009, 22:232-240.
- [29]Franssen CF, Dasselaar JJ, Sytsma P, Burgerhof JG, de Jong PE, Huisman RM: Automatic feedback control of relative blood volume changes during hemodialysis improves blood pressure stability during and after dialysis. Hemodial Int 2005, 9:383-392.
- [30]Mancini E, Santoro A, Spongano M, Paolini F, Zucchelli P: Effects of automatic blood volume control over intradialytic hemodynamic stability. Int J Artif Organs 1995, 18:495-498.
- [31]Ronco C, Brendolan A, Milan M, Rodeghiero MP, Zanella M, La Greca G: Impact of biofeedback-induced cardiovascular stability on hemodialysis tolerance and efficiency. Kidney Int 2000, 58:800-808.
- [32]Santoro A, Mancini E: Blood volume monitoring systems and biofeedback. Contrib Nephrol 2002, 137:233-244.
- [33]Santoro A, Mancini E, Paolini F, Spongano M, Zucchelli P: Automatic control of blood volume trends during hemodialysis. ASAIO J 1994, 40:M419-422.
- [34]Winkler RE, Patow W, Ahrenholz P: Blood volume monitoring. Contrib Nephrol 2008, 161:119-124.
- [35]Wolkotte C, Hassell DR, Moret K, Gerlag PG, van den Wall Bake AW, van der Sande FM, Kooman JP: Blood volume control by biofeedback and dialysis-induced symptomatology. A short-term clinical study. Nephron 2002, 92:605-609.
- [36]Polaschegg HDDevice for treating blood in an extracorporeal system. European Patent EP0265791, priority 16.10.1986
- [37]Levin NW, Kotanko P: Is cool dialysis an effective and well-tolerated means of reducing the frequency of intradialytic hypotension? Nat Clin Pract Nephrol 2006, 2:670-671.
- [38]Selby NM, McIntyre CW: A systematic review of the clinical effects of reducing dialysate fluid temperature. Nephrol Dial Transplant 2006, 21:1883-1898.
- [39]Donnan F: The theory of membrane equilibria. Chem Rev 1924, 1:73-90.
- [40]Stiller S, Mann H: The Donnan effect in artificial kidney therapy. Life Support Syst 1986, 4:305-318.
- [41]Nolph KD, Stoltz ML, Carter CB, Fox M, Maher JF: Factors affecting the composition of ultrafiltrate from hemodialysis coils. Trans Am Soc Artif Intern Organs 1970, 16:495-501.
- [42]Locatelli F, Ponti R, Pedrini L, Di Filippo S: Sodium and dialysis: a deeper insight. Int J Artif Organs 1989, 12:71-74.
- [43]Lopot F, Kotyk P, Blaha J, Valek A: Influence of the dialyzer membrane material on sodium transport in hemodialysis. Artif Organs 1995, 19:1172-1175.
- [44]Weichhart T, Kopecky C, Kubicek M, Haidinger M, Döller D, Katholnig K, Suarna C, Eller P, Tölle M, Gerner C, Zlabinger GJ, van der Giet M, Hörl WH, Stocker R, Säemann MD: Serum amyloid A in uremic HDL promotes inflammation. In J Am Soc Nephrol 2012, 23:934-47.
- [45]Rhee EP, Souza A, Farrell L, Pollak MR, Lewis GD, Steele DJ, Thadhani R, Clish CB, Greka A, Gerszten RE: Metabolite profiling identifies markers of uremia. J Am Soc Nephrol 2010, 21:1041-1051.
- [46]Feroze U, Kalantar-Zadeh K, Sterling KA, Molnar MZ, Noori N, Benner D, Shah V, Dwivedi R, Becker K, Kovesdy CP, Raj DS: Examining associations of circulating endotoxin with nutritional status, inflammation, and mortality in hemodialysis patients. J Ren Nutr 2012, 22:317-26.
- [47]McIntyre CW, Harrison LE, Eldehni MT, Jefferies HJ, Szeto CC, John SG, Sigrist MK, Burton JO, Hothi D, Korsheed S, Owen PJ, Lai KB, Li PK: Circulating endotoxemia: a novel factor in systemic inflammation and cardiovascular disease in chronic kidney disease. Clin J Am Soc Nephrol 2011, 6:133-141.
- [48]Mapes DL, Lopes AA, Satayathum S, McCullough KP, Goodkin DA, Locatelli F, Fukuhara S, Young EW, Kurokawa K, Saito A, Bommer J, Wolfe RA, Held PJ, Port FK: Health-related quality of life as a predictor of mortality and hospitalization: the dialysis outcomes and practice patterns study (DOPPS). Kidney Int 2003, 64:339-349.
- [49]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, 33:39-48.
- [50]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, 59:238-48.
- [51]She R: Research Randomizer (Version 3.0). http://www.randomizer.org/ webcite
- [52]Hörl WH, Koch KM, Lindsay RM, Ronco C, Winchester JF: Replacement of renal function by dialysis. 5th edition. Kluwer Academic Publishers, Dordrecht, The Netherlands; 2004.
- [53]Machek P, Jirka T, Moissl U, Chamney P, Wabel P: Guided optimization of fluid status in haemodialysis patients. Nephrol Dial Transplant 2010, 25:538-544.
- [54]Chazot C, Wabel P, Chamney P, Moissl U, Wieskotten S, Wizemann V: Importance of normohydration for the long-term survival of haemodialysis patients. Nephrol Dial Transplant 2012, 27(6):2404-2410. Epub 2012 Jan
- [55]Mailloux LU, Haley WE: Hypertension in the ESRD patient: pathophysiology, therapy, outcomes, and future directions. Am J Kidney Dis 1998, 32:705-719.
- [56]Levin NW, Kotanko P, Eckardt KU, Kasiske BL, Chazot C, Cheung AK, Redon J, Wheeler DC, Zoccali C, London GM: Blood pressure in chronic kidney disease stage 5D-report from a kidney disease: improving global outcomes controversies conference. Kidney Int 2010, 77:273-284.
- [57]Agarwal R, Weir MR: Dry-weight: a concept revisited in an effort to avoid medication-directed approaches for blood pressure control in hemodialysis patients. Clin J Am Soc Nephrol 2010, 5:1255-1260.
- [58]Heerspink HJ, Ninomiya T, Zoungas S, de Zeeuw D, Grobbee DE, Jardine MJ, Gallagher M, Roberts MA, Cass A, Neal B, Perkovic V: Effect of lowering blood pressure on cardiovascular events and mortality in patients on dialysis: a systematic review and meta-analysis of randomised controlled trials. Lancet 2009, 373:1009-1015.
- [59]Agarwal R, Sinha AD: Cardiovascular protection with antihypertensive drugs in dialysis patients: systematic review and meta-analysis. Hypertension 2009, 53:860-866.
- [60]Fernandez JM, Carbonell ME, Mazzuchi N, Petruccelli D: Simultaneous analysis of morbidity and mortality factors in chronic hemodialysis patients. Kidney Int 1992, 41:1029-1034.
- [61]Goldsmith DJ, Covic AC, Venning MC, Ackrill P: Ambulatory blood pressure monitoring in renal dialysis and transplant patients. Am J Kidney Dis 1997, 29:593-600.
- [62]Ozkahya M, Toz H, Unsal A, Ozerkan F, Asci G, Gurgun C, Akcicek F, Mees EJ: Treatment of hypertension in dialysis patients by ultrafiltration: role of cardiac dilatation and time factor. Am J Kidney Dis 1999, 34:218-221.
- [63]Charra B: Control of blood pressure in long slow hemodialysis. Blood Purif 1994, 12:252-258.
- [64]Charra B, Calemard E, Ruffet M, Chazot C, Terrat JC, Vanel T, Laurent G: Survival as an index of adequacy of dialysis. Kidney Int 1992, 41:1286-1291.
- [65]Port FK, Hulbert-Shearon TE, Wolfe RA, Bloembergen WE, Golper TA, Agodoa LY, Young EW: Predialysis blood pressure and mortality risk in a national sample of maintenance hemodialysis patients. Am J Kidney Dis 1999, 33:507-517.
- [66]Li Z, Lacson E, Lowrie EG, Ofsthun NJ, Kuhlmann MK, Lazarus JM, Levin NW: The epidemiology of systolic blood pressure and death risk in hemodialysis patients. Am J Kidney Dis 2006, 48:606-615.
- [67]Hecking M, Karaboyas A, Saran R, Sen A, Inaba M, Rayner H, Horl WH, Pisoni RL, Robinson BM, Sunder-Plassmann G, Port FK: Dialysate sodium concentration and the association with interdialytic weight gain, hospitalization, and mortality. Clin J Am Soc Nephrol 2012, 7:92-100.
- [68]Lindley EJ: Reducing sodium intake in hemodialysis patients. Semin Dial 2009, 22:260-263.
- [69]Khan NA, Hemmelgarn BR, Tonelli M, Thompson CR, Levin A: Prognostic value of troponin T and I among asymptomatic patients with end-stage renal disease: a meta-analysis. Circulation 2005, 112:3088-3096.
- [70]Kirmizis D, Tsiandoulas A, Pangalou M, Koutoupa E, Rozi P, Protopappa M, Barboutis K: Validity of plasma fibrinogen, D-dimer, and the von Willebrand factor as markers of cardiovascular morbidity in patients on chronic hemodialysis. Med Sci Monit 2006, 12:CR55-CR62.
- [71]Chazot C, Vo-Van C, Zaoui E, Vanel T, Hurot JM, Lorriaux C, Mayor B, Deleaval P, Jean G: Fluid overload correction and cardiac history influence brain natriuretic peptide evolution in incident haemodialysis patients. Nephrol Dial Transplant 2011, 26:2630-2634.