Cardiovascular risk and mortality in end-stage renal disease patients undergoing dialysis: sleep study, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life: a prospective, double blind, randomized controlled clinical trial

BMC Nephrology

Luis Vicente Franco Oliveira⁹  Daniel Giannella-Neto⁷  Nadia Karina Guimarães Souza⁷  Humberto Dellê⁷  Ana Karina Fachini Araujo⁵  Giuseppe Insalaco¹  Salvatore Romano¹  Lílian Christiane Giannasi⁸  Luciana Maria Malosá Sampaio⁶  Paulo de Tarso Camillo de Carvalho⁶  Sérgio Roberto Nacif⁶  Fernando Sérgio Studart Leitão Filho²  Viviane Cristina Delgado Lopes^1,10  Vinicius Alves Thomaz Fernandes^1,10  Virgilio Fernandes^1,10  Nina Teixeira Fonsêca⁴  Leonardo Macario Ferraz⁵  Aline Almeida Martins⁵  Jessica Julioti Urbano³  Ismael Souza Dias³  Ezequiel Fernandes Oliveira⁶  Isabella de Carvalho Aguiar⁶  Aline Roberta Danaga⁶  Israel dos Reis Santos⁶ 

[1] Istituto di Biomedicina e di Immunologia Molecolare “Alberto Monroy” (IBIM), CNR, Palermo, SI, Italy;Medicine School, Fortaleza University (UNIFOR), Fortaleza, CE, Brazil;Physical Therapy School, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil;Physical Therapy School, Universidade Estadual de Ciências da Saúde de Alagoas (UNCISAL), Maceió, AL, Brazil;Psychology School, Health Department, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil;Rehabilitation Sciences Master Degree and PhD Program, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil;Medicine Master Degree Program, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil;Bioscience Department, Universidade Estadual Paulista (UNESP/SJC), São Paulo, SP, Brazil;Sleep Laboratory, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil;Centro de Nefrologia Zona Norte (CENENORTE), São Paulo, SP, Brazil

关键词: Quality of life;    Sleep;    Dialysis;    Chronic kidney disease;   

Others  :  1082824
DOI  :  10.1186/1471-2369-14-215

 received in 2013-08-08, accepted in 2013-10-03,  发布年份 2013

【 摘 要 】

Background

Chronic kidney disease (CKD) is one of the most serious public health problems. The increasing prevalence of CKD in developed and developing countries has led to a global epidemic. The hypothesis proposed is that patients undergoing dialysis would experience a marked negative influence on physiological variables of sleep and autonomic nervous system activity, compromising quality of life.

Methods/Design

A prospective, consecutive, double blind, randomized controlled clinical trial is proposed to address the effect of dialysis on sleep, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life in patients with CKD. The measurement protocol will include body weight (kg); height (cm); body mass index calculated as weight/height²; circumferences (cm) of the neck, waist, and hip; heart and respiratory rates; blood pressures; Mallampati index; tonsil index; heart rate variability; maximum ventilatory pressures; negative expiratory pressure test, and polysomnography (sleep study), as well as the administration of specific questionnaires addressing sleep apnea, excessive daytime sleepiness, depression, anxiety, stress, and quality of life.

Discussion

CKD is a major public health problem worldwide, and its incidence has increased in part by the increased life expectancy and increasing number of cases of diabetes mellitus and hypertension. Sleep disorders are common in patients with renal insufficiency. Our hypothesis is that the weather weight gain due to volume overload observed during interdialytic period will influence the degree of collapsibility of the upper airway due to narrowing and predispose to upper airway occlusion during sleep, and to investigate the negative influences of haemodialysis in the physiological variables of sleep, and autonomic nervous system, and respiratory mechanics and thereby compromise the quality of life of patients.

Trial registration

The protocol for this study is registered with the Brazilian Registry of Clinical Trials (ReBEC RBR-7yhr4w and World Health Organization under Universal Trial Number UTN: U1111-1127-9390 [http://www.ensaiosclinicos.gov.br/rg/RBR-7yhr4w/ webcite]).

【 授权许可】

   
2013 dos Reis Santos et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Jurkovitz CT, Elliott D, Li S, Saab G, Bomback AS, Norris KC, et al.: Physician utilization, risk-factor control, and CKD progression among participants in the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis 2012, 59(3 Suppl 2):S24-S33.
• [2]Moura L, Schmidt MI, Duncan BB, Rosa RS, Malta DC, Stevens A, et al.: Monitoring end stage renal disease through the high complexity procedures authorization subsystem–Apc- in Brazil (2000–2006). Epidemiol Serv Saúde 2009, 18(2):121-131.
• [3]Mula-Abed WA, Al Rasadi K, Al-Riyami D: Estimated Glomerular Filtration Rate (eGFR): a serum creatinine-based test for the detection of chronic kidney disease and its impact on clinical practice. Oman Med J 2012, 27(2):108-113.
• [4]Jung HH, Lee JH, Baek HJ, Kim SJ, Lee JJ: Nocturnal hypoxemia and periodic limb movement in patients on maintenance hemodialysis. Clim J AM Soc Nephrol 2010, 5(9):1607-1613.
• [5]Beecroft JM, Hoffstein V, Pierratos A, Chan CT, McFarlane PA, Hanly PJ: Pharyngeal narrowing in end-stage renal disease: implications for obstructive sleep apnoea. Eur Respir J 2007, 30(5):965-971.
• [6]Weiner DE, Tighiouart H, Stark PC, Amin MG, MacLeod B, Griffith JL, et al.: Kidney disease as a risk factor for recurrent cardiovascular disease and mortality. Am J Kidney Dis 2004, 44(2):198-206.
• [7]Zoccali C, Mallamaci F, Tripepi G: Novel cardiovascular risk factors in end-stage renal disease. J Am Soc Nephrol 2004, 15(Suppl 1):S77-S80.
• [8]Drager LF, Bortolotto LA, Krieger EM, Lorenzi-Filho G: Additive effects of obstructive sleep apnea and hypertension on early markers of carotid atherosclerosis. Hypertension 2009, 53(1):64-69.
• [9]Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, et al.: Association of sleep-disordered breathing, sleep apnea and hypertension in a large community-based study. Sleep Heart Health Study. JAMA 2000, 283(14):1829-1836.
• [10]Mclntyre CW, Selby NM, Sigrist M, Pearce LE, Mercer TH, Naish PF: Patients receiving maintenance dialysis have more severe functionally significant skeletal muscle wasting than patients with dialysis-independent chronic kidney disease. Nephrol Dial Transplant 2006, 21(8):2210-2216.
• [11]Cury JL, Brunetto AF, Aydos RD: Negative effects of chronic kidney failure on lung function and function capacity. Rev Bras Fisioter 2010, 14(2):91-98.
• [12]Miyazaki ET, Dos Santos R JR, Miayaki MC, Domingos NM, Felicio HC, Rocha MF, et al.: Patients on the waiting list for liver transplantation: caregiver burden and stress. Liver Transpl 2010, 16(10):1164-1168.
• [13]Chilcot J, Wellsted D, Farrington K: Screening for depression while patients dialyse: an evaluation. Nephrol Dial Transplant 2008, 23(8):2653-2659.
• [14]Kimmel PL, Peterson RA, Weihs KL, Simmens SJ, Alleyne S, Cruz I, et al.: Multiple measurements of depression predict mortality in a longitudinal study of chronic hemodialysis outpatients. Kidney Int 2000, 57(5):2093-2098.
• [15]Faries D, Herrara J, Rayamajhi J, DeBrota D, Demitrack M, Potter WZ: The responsiveness of Hamilton Depression Rating Scale. J Psychiatr Res 2000, 34(1):3-10.
• [16]Punjabi NM: The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc 2008, 5(2):136-143.
• [17]Tufik S, Santos-Silva R, Taddei JA, Bittencourt LR: Obstructive sleep apnea syndrome in the Sao Paulo Epidemiologic Sleep Study. Sleep Med 2010, 11(5):441-446.
• [18]Sim JJ, Rasgon SA, Derose SF: Review article: managing sleep apnoea in kidney diseases. Nephrology (Carlton) 2010, 15(2):146-152.
• [19]Hanly P: Sleep apnea and daytime sleepiness in end-stage renal disease. Semin Dial 2004, 17(2):109-114.
• [20]Dement WC: The study of human sleep: a historical perspective. Thorax 1998, 53(Suppl 3):S2-S7.
• [21]Liistro G, Rombaux PH, Belge C, Dury M, Aubert G, Rodenstein DO: High mallampati score and nasal obstruction are associated risk factors for obstructive sleep apnoea. Eur Respir J 2003, 21(2):248-252.
• [22]Nakata S, Noda A, Yanagi E, Suzuki K, Yamamoto H, Nakashima T: Tonsil size and body index are importante factors for efficacy of simple tonsillectomy in obstructive apnoea syndrome. Clin Otolaryngol 2006, 31(1):41-45.
• [23]Chan CT, Hanly P, Gabor J, Picton P, Pierratos A, Floras JS: Impact of nocturnal hemodialysis on the variability of heart rate and duration of hypoxemia during sleep. Kidney Int 2004, 65(2):661-665.
• [24]Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP: Using the Berlin questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med 1999, 131(7):485-491.
• [25]Johns MW: A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991, 14(6):540-545.
• [26]Ciconelli RM, Ferraz MB, Santos W, Meinão I, Quaresma MR: Tradução para a língua portuguesa e validação de questionário genérico de avaliação de qualidade de vida SF-36 (Brasil SF-36). Rev Bras de Reumatol 1999, 39(3):143-150.
• [27]Lacson E Jr, Xu J, Lin SF, Dean SG, Lazarus JM, Hakin RM: A comparison of SF-36 and SF-12 composite scores and subsequent hospitalization and mortality risks in long-term dialysis patients. Clin J Am Soc Nephrol 2010, 5(2):252-260.
• [28]Gabrielsen AM, Lund MB, Kongerud J, Viken KE, Roislien J, Hjelmesaeth J: The relationship between anthropometric measures, blood gases, and lung function in morbidly obese white subjects. Obes Surg 2011, 21(4):485-491.
• [29]Costa D, Sampaio LM, De Lorenzzo VA, Jamami M, Damaso AR: Avaliação da força muscular respiratória e amplitudes torácicas e abdominais após a RFR em indivíduos obesos. Rev Lat Am Enfermagem 2003, 11(2):156-160.
• [30]Pereira CA: II Consenso Brasileiro de Espirometria. J Pneumol 2002, 28(Suppl 3):S1-S82.
• [31]Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC: Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl 1993, 16:5-40.
• [32]Magnani KL, Cataneo AJM: Respiratory muscle strength in obese individuals and influence of upper-body fat distribution. Sao Paulo Med J 2007, 125(4):215-219.
• [33]Murray WJ: Reliability and factor analysis of Epowoth Sleepiness Scale. Sleep 1992, 15(4):376-381.
• [34]Rechtschaffen A, Rechtschaffen A, Kales A: A manual of standardized terminology: techniques and scoring system for sleep stages of human subjects. In Psychiatry and Clinical Neurosciences. Volume 55. Los Angeles: Brain Information Service/Brain Research Institute; 1968; 2001:305-310.
• [35]Iber C, Ancoli-Israel S, Chesson A, Quan S, for the American Academy of Sleep Medicine: The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications. 1st edition. Westchester, IL: American Academy of Sleep Medicine; 2007.
• [36]Isono S, Tanaka A, Tagaito Y, Ishikawa T, Nishino T: Influences of head positions and bite opening on collapsibility of the passive pharynx. J Appl Physiol 2004, 97(1):339-346.
• [37]Romano S, Salvaggio A, Hirata RP, Lo Bue A, Picciolo S, Oliveira LVF, et al.: Upper airway collapsibility evaluated by negative expiratory pressure test in severe obstructive sleep apnea. Clinics (Sao Paulo) 2011, 66(4):567-572.
• [38]Task force of the European Society of Cardiology the North American Society of pacing electrophysiology: Heart rate variability: standards of measurement, physiological interpretation, and clinical use. Circulation 1996, 93:1043-1065.
• [39]Terechtchenko L, Doronina SA, Pochinok EM, Riftine A: Autonomic tone in patients with supraventricular arrhythmia associated with mitral valve prolapse in young men. PACE 2003, 26(1 Pt2):444-446.
• [40]Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatr 1960, 23:56-62.
• [41]Hamilton M: Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 1967, 6(4):278-296.
• [42]Park J, Ann SH, Chung HC, Lee JS, Kim SJ, et al.: Remote ischemic preconditioning in hemodialysis: a pilot study. Heart Vessels 2013. doi:10.1007/s00380-013-0329-y
• [43]Redline S, Yenokyan G, Gottlieb DJ, et al.: Obstructive sleep apnea–hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med 2010, 182:269-277.
• [44]Gottlieb DJ, Yenokyan G, Newman AB, et al.: Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation 2010, 122:352-360.
• [45]Sakaguchi Y, Shoji T, Kawabata H, Niihata K, Suzuki A, Kaneko T, et al.: High prevalence of obstructive sleep apnea and its association with renal function among nondialysis chronic kidney disease patients in Japan: a cross-sectional study. Clin J Am Soc Nephrol 2011, 6:995-1000.
• [46]Drager LF, Ladeira RT, Brandão-Neto RA, Lorenzi-Filho G, Benseñor IM: Síndrome da apnéia obstrutiva do sono e sua relação com a hipertensão arterial sistêmica: evidências atuais. Arq Bras Cardiol 2002, 78:531-536.