Soluções tamponadas versus soro fisiológico para ressuscitação de adultos e crianças em estado grave: uma Revisão Cochrane
Palavras-chave:
Critical Illness, Critical Care, Fluid Therapy, Hospital Mortality, Randomized Controlled Trials as Topic, Rehydration Solutions, Saline SolutionResumo
Introdução: A fluidoterapia é uma das principais intervenções usadas nos pacientes em estado crítico. Porém, não existe consenso quanto ao tipo de solução a ser utilizada. Entre as soluções cristaloides, a solução salina a 0,9% é a mais frequentemente administrada. Em teoria, o uso de soluções tamponadas poderia trazer algumas vantagens (menos acidose metabólica, menos distúrbios eletrolíticos). Porém, a relevância clínica desse tipo de fluidoterapia permanece desconhecida.
Objetivos: O objetivo dessa revisão foi avaliar os efeitos das soluções tamponadas versus soluções salinas a 0,9% no manejo de adultos e crianças em estado crítico.
Métodos de Busca: Fizemos buscas nos seguintes bancos de dados até julho de 2018: CENTRAL, MEDLINE, Embase, CINAHL e quatro plataformas de registros de ensaios clínicos. Também revisamos listas de referências, e fizemos buscas para frente e para trás dos artigos relevantes. Entramos em contato com os autores dos estudos para identificar estudos adicionais. Não houve restrição de idiomas.
Critério de seleção: Incluímos ensaios clínicos randomizados (ECRs) com desenho paralelo ou cruzado, que testaram o uso de soluções tamponadas versus solução salina a 0,9% em unidades de terapia intensiva (para ressuscitação ou manutenção). Incluímos estudos envolvendo participantes em estado crítico (incluindo trauma e queimaduras) ou submetidos a cirurgia de emergência, durante tratamento de doenças graves, em que se fez necessária a fluidoterapia endovenosa. Incluímos estudos envolvendo adultos e crianças. Incluímos estudos com mais de dois braços desde que preenchessem todos nossos critérios de inclusão. Excluímos estudos envolvendo pessoas submetidas a cirurgias eletivas e estudos com múltiplas intervenções no mesmo grupo de participantes.
Coleta dos dados e análises: Usamos a metodologia padrão da Cochrane. Avaliamos os efeitos da intervenção com metanálises usando o modelo de efeitos aleatórios. Porém, usamos o modelo de efeito fixo quando um ou dois estudos contribuíram com 75% dos participantes. Calculamos os intervalos de confiança (IC) de 95% para as estimativas de efeito.
Principais resultados: Incluímos 21 ECRs (20.213 participantes) e identificamos três estudos em andamento. Três ECRs contribuíram com 19.054 participantes (94,2%). Quatro ECRs (402 participantes) foram realizados em crianças com desidratação grave e síndrome do choque da dengue. Quatorze estudos apresentaram dados de mortalidade, e nove tinham dados sobre lesão renal aguda. Dezesseis ECRs recrutaram adultos e quatro recrutaram crianças. Um estudo não estabeleceu limites de idade máxima ou mínima para inclusão dos participantes. Oito estudos envolvendo 19.218 participantes foram classificados como de alta qualidade metodológica. Esses foram ECRs com baixo risco geral de viés, baseado na avaliação dos seguintes domínios: ocultação de alocação, cegamento dos participantes/avaliadores dos desfechos, dados incompletos e relato seletivo dos desfechos. Os outros ECRs tinham algum tipo de viés ou essa possibilidade não podia ser descartada.
Não existe evidência de que as soluções tamponadas modificam a mortalidade hospitalar (odds ratio‐ OR 0,91, IC 95% 0,83 a 1,01; 19.664 participantes; 14 estudos; evidência de alta qualidade). Presumindo uma taxa de mortalidade de 119 a cada 1000, as soluções tamponadas podem reduzir a mortalidade em 21 a cada 1000 ou podem aumentar a mortalidade em 1 a cada 1000. Da mesma forma, não existe evidência do efeito das soluções tamponadas sobre lesões renais agudas (OR 0,92, IC 95% 0,84 a 1,00; 18.701 participantes; 9 estudos; evidência de baixa qualidade). Presumindo uma taxa de 121 a cada 1000, as soluções tamponadas podem reduzir a taxa de lesão renal aguda em 19 a cada 1000, ou não causar nenhuma diferença na taxa de lesão renal aguda. As soluções tamponadas não modificaram o risco de disfunção orgânica (OR 0,80, IC 95% 0,40 a 1,61; 266 participantes; 5 estudos; evidência de baixa qualidade). As evidências sobre os efeitos das soluções tamponadas nos distúrbios eletrolíticos foram variadas: potássio (diferença média (DM) 0,09, IC 95% ‐0,10 a 0,27; 158 participantes; 4 estudos; evidência de qualidade muito baixa); cloreto (MD ‐3,02, IC 95% ‐5,24 a ‐0,80; 351 participantes; 7 estudos; evidência de qualidade muito baixa); pH (MD 0,04, IC 95% 0,02 a 0,06; 200 participantes; 3 estudos; evidências de qualidade muito baixa); e bicarbonato (MD 2,26, IC 95% 1,25 a 3,27; 344 participantes; 6 estudos; evidência de qualidade muito baixa).
Conclusão dos autores: Não há nenhum efeito do uso de soluções tamponadas na prevenção da mortalidade hospitalar, em comparação com o uso de solução salina a 0,9%, em pacientes graves. A qualidade da evidência para esse achado foi alta. Isso indica que é provável que novas pesquisas encontrem pouca ou nenhuma diferença na taxa de mortalidade. Os efeitos das soluções tamponadas versus solução salina a 0,9% na prevenção de lesões renais agudas foram semelhantes. A qualidade da evidência para esse resultado é baixa. Isso significa que novas pesquisas podem vir mudar essa conclusão. Os pacientes tratados com soluções tamponadas apresentaram níveis mais baixos de cloreto, níveis mais elevados de bicarbonato e pH mais alto. A qualidade da evidência para esses resultados é muito baixa. Pesquisas futuras devem avaliar desfechos relevantes para os pacientes, como qualidade de vida. Os três estudos em andamento, uma vez publicados e avaliados, podem alterar as conclusões da revisão.
Referências
References to studies included in this review:
ditianingsih 2017 {published data only}
Aditianingsih D, Djaja AS, George YW. The effect of balanced electrolyte solution versus normal saline in the prevention of hyperchloremic metabolic acidosis in diabetic ketoacidosis patients: a randomized controlled trial. Medical Journal of Indonesia 2017;26(2):134‐40. [DOI: 10.13181/mji.v26i2.1542]
Allen 2016 {published data only}
Allen CH, Goldman RD, Bhatt S, Simon HK, Gorelick MH, Spandorfer PR, et al. A randomized trial of Plasma‐Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis. BMC Pediatrics 2016;16:117. [PUBMED: 27480410]
Choosakul 2018 {published data only}
Choosakul S, Harinwan K, Chirapongsathorn S, Opuchar K, Sanpajit T, Piyanirun W, et al. Comparison of normal saline versus Lactated Ringer's solution for fluid resuscitation in patients with mild acute pancreatitis, a randomized controlled trial. Pancreatology 2018;18(5):507‐12. [PUBMED: 29754857]
de‐Madaira 2018 {published data only}
de‐Madaria E, Herrera‐Marante I, González‐Camacho V, Bonjoch L, Quesada‐Vázquez N, Almenta‐Saavedra I, et al. Fluid resuscitation with lactated Ringer's solution vs normal saline in acute pancreatitis: a triple‐blind, randomized, controlled trial. United European Gastroenterology Journal 2018;6(1):63‐72. [PUBMED: 29435315 ]
Dung 1999 {published data only}
Dung NM, Day NP, Tam DT, Loan HT, Chau HT, Minh LN, et al. Fluid replacement in dengue shock syndrome: a randomized, double‐blind comparison of four intravenous‐fluid regimens. Clinical Infectious Diseases 1999;4:787‐94. [PUBMED: 10589889]
Hasman 2012 {published data only}
Hasman H, Cinar O, Uzun A, Cevik E, Jay L, Comert B. A randomized clinical trial comparing the effect of rapidly infused crystalloids on acid‐base status in dehydrated patients in the emergency department. International Journal of Medical Sciences 2012;9(1):59‐64. [PUBMED: 22211091]
Hassan 2017 {published data only}
Hassan MH, Wan Hassan WM, Zaini RH, Shukeri WF, Abidin HZ, Eu CS. Balanced fluid versus saline‐based fluid in post‐operative severe traumatic brain injury patients: acid‐base and electrolytes assessment. Malaysian Journal of Medical Sciences 2017;24(5):83‐93. [PUBMED: 29386975 ]
Mahajan 2012 {published data only}
Mahajan V, Saini SS, Sharma A, Kaur J. Ringer's lactate vs normal saline for children with acute diarrhoea and severe dehydration: a double blind randomized controlled trial. Indian Pediatrics 2012;49(12):963‐8. [PUBMED: 22791671]
Mahler 2011 {published data only}
Mahler SA, Conrad SA, Wang H, Arnold TC. Resuscitation with balanced electrolyte solution prevents hyperchloremic metabolic acidosis in patients with diabetic ketoacidosis. American Journal of Emergency Medicine 2011;29(6):670‐4. [PUBMED: 20825879 ]
Ngo 2001 {published data only}
Ngo NT, Cao XT, Kneen R, Wills B, Nguyen VM, Nguyen TQ, et al. Acute management of dengue shock syndrome: a randomized double‐blind comparison of 4 intravenous fluid regimens in the first hour. Clinical Infectious Diseases 2001;32(2):204‐3. [PUBMED: 11170909 ]
Ratanarat 2017 {published data only}
Ratanarat R, Sanguanwit P, Chitsomkasem A. The effects of normal saline versus balanced crystalloid solution as a resuscitation fluid on acute kidney injury in shock patients: a randomized opened label controlled trial. Intensive Care Medicine Experimental 2017;5(Suppl 2):S201. [PUBMED: 28933044]
Reddy 2014 {published data only}
Reddy YR, Talukder S, Yadav TD, Siddappa PK, Kochhar R. Effect of intravenous fluid resuscitation on inflammatory markers of acute pancreatitis and its clinical outcome. United European Gastroenterology Journal 2014;2(1 Suppl):132‐5. [DOI: 10.1177/2050640614548980]
Semler 2016 {published data only}
Semler MW, Wanderer JP, Ehrenfeld JM, Stollings JL, Self WH, Siew ED, et al. Balanced crystalloids versus saline in the intensive care unit: the SALT randomized trial. American Journal of Respiratory and Critical Care Medicine 2017;195(10):1362‐72. [PUBMED: 27749094]
Semler 2018 {published data only}
Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, et al. Balanced crystalloids versus saline in critically ill adults. New England Journal of Medicine 2018;378(9):829‐39. [PUBMED: 29485925 ]
Van Zyl 2012 {published data only}
Van Zyl DG, Rheeder P, Delport E. Fluid management in diabetic acidosis Ringer's lactate versus normal saline: a randomized controlled trial. Quarterly Journal of Medicine 2012;105(4):337‐43. [PUBMED: 22109683]
Vasu 2013 {published data only}
Vasudevan P, Verma GR, Naveen Kalra AB, Basha J, Appasani S, et al. Does the type of fluid used in resuscitation matter in the clinical course of acute pancreatitis?. Indian Journal of Gastroenterology 2013;32(1 Suppl):110. [PUBMED: 24233855]
Verma 2016 {published data only}
Verma B, Luethi N, Cioccari L, Lloyd‐Donald P, Crisman M, Eastwood G, et al. A multicentre randomised controlled pilot study of fluid resuscitation with saline or Plasma‐Lyte 148 in critically ill patients. Critical Care and Resuscitation: Journal of the Australasian Academy of Critical Care Medicine 2016;18(3):205‐12. [PUBMED: 27604335]
Viaene 2014 {published data only}
Viaene F, Bourgeois M, Decruyenaere J, Hoste E. Balanced versus unbalanced: does a small volume of sterofundin versus NACL 0.9 % make a difference?. Intensive Care Medicine 2014;40(1 Suppl):222. [PUBMED: 25253128]
Wu 2011 {published data only}
Wu BU, Hwang JQ, Gardner TH, Repas K, Delee R, Yu S, et al. Lactated Ringer's solution reduces systemic inflammation compared with saline in patients with acute pancreatitis. Clinical Gastroenterology and Hepatology 2011;9(8):710‐7. [PUBMED: 21645639]
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Smith CA, Duby JJ, Utter GH, Galante JM, Scherer LA, Schermer CR. Cost‐minimization analysis of two fluid products for resuscitation of critically injured trauma patients. American Journal of Health‐System Pharmacy 2014;71(6):470‐5. [PUBMED: 24589538]
Smith CA, Gosselin RC, Utter GH, Galante JM, Young JB, Scherer LA, et al. Does saline resuscitation affect mechanisms of coagulopathy in critically ill trauma patients? An exploratory analysis. Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis 2015;26(3):250‐4. [PUBMED: 25803514 ]
Young JB, Utter GH, Schermer CR, Galante JM, Phan HH, Yang Y, et al. Saline versus Plasma‐Lyte A in initial resuscitation of trauma patients: a randomized trial. Annals of Surgery 2014;259(2):255‐62. [PUBMED: 23732264]
Young 2015 {published data only}
Reddy SK, Bailey MJ, Beasley RW, Bellomo R, Henderson SJ, Mackle DM, et al. A protocol for the 0.9% saline versus Plasma‐Lyte 148 for intensive care fluid therapy (SPLIT) study. Critical Care Resuscitation 2014;16(4):274‐9. [PUBMED: 25437221]
Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, et al. Effect of a buffered crystalloid solution vs saline on acute kidney injury among patients in the intensive care unit: the SPLIT randomized clinical trial. JAMA 2015;314(16):1701‐10. [PUBMED: 26444692]
References to studies excluded from this review:
Benoit 2016 {published data only}
Benoit D, Crivits M, Hemeryck M, Hoste E, Raes M, Viaene F. Small volume fluid infusion with balanced or un‐balanced fluids: does it make a difference?. Journal of the Intensive Care Society 2016;17(3 Suppl):S41. [PUBMED: 30160259 ]
Chen XL, Xia ZF. Clinical study on the changes in plasma sodium level and blood erythrocyte after resuscitation with different fluid regimes at early postburn stage. Zhonghua Shao Shang Za Zhi 2004;20(5):284‐6. [PUBMED: 15730653]
Cho 2007 {published data only}
Cho YS, Lim H, Kim SH. Comparison of lactated Ringer's solution and 0.9% saline in the treatment of rhabdomyolysis induced by doxylamine intoxication. Emergency Medicine Journal 2007;24(4):276‐80. [PUBMED: 17384382]
Crivits 2016 {published data only}
Crivits M, Raes M, Decruyenaere J, Hoste E. Volume bolus in ICU patients: do we need to balance our crystalloids?. Critical Care 2016;20(Suppl 2):73. [PUBMED: 27885969]
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Dybvik T, Strand T, Steen PA. Buffer therapy during out‐of‐hospital resuscitation. Resuscitation 1995;29(2):89‐5. [PUBMED: 7659873]
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Fang ZX, Li YF, Zhou XQ, Zhang Z, Zhang JS, Xia HM, et al. Effects of resuscitation with crystalloid fluids on cardiac function in patients with severe sepsis. BMC Infectious Diseases 2008;8:50. [PUBMED: 18419825]
Galas 2009 {published data only}
Galas F, Hajjar L, Simoes C, Vieira S, Kalil FR, Auler J. Effects of Ringer's lactate or Ringerfundin resuscitation on the acid‐base status and serum electrolytes in septic oncologic patients. Critical Care 2009;13(1 Suppl):180. [PUBMED: 19344483]
Kartha 2017 {published data only}
Kartha GB, Rameshkumar R, Mahadevan S. Randomized double‐blind trial of ringer lactate versus normal saline in pediatric acute severe diarrhoeal dehydration. Journal of Pediatric Gastroenterology and Nutrition 2017;65(6):621‐6. [PUBMED: 28422812]
Martin 2018 {published data only}
Friederich A, Martin N, Swanson MB, Faine BA, Mohr NM. Normal saline solution and lactated Ringer's solution have a similar effect on quality of recovery: a randomized controlled trial. Annals Emergency Medicine 2018;18:1‐10. [PUBMED: 30146446]
Omar 2018 {published data only}
Omar S, Mathivha LR. A randomized trial comparing two balanced fluids in the critically ill. Critical Care 2018;22(1 Suppl):126. [DOI: 10.1186/s13054‐018‐1973‐5]
Rainier‐Pope 1962 {published data only}
Rainier‐Pope CR. Fluid therapy in gastro‐enteritis with severe dehydration. A biochemically controlled trial of a regime in 40 patients. South African Medical Journal 1962;36:1087‐91. [PUBMED: 13990516]
Roquilly 2013 {published data only}
Roquilly A, Loutrel O, Cinotti R, Rosenczweig E, Flet L, Mahe PJ, et al. Balanced versus chloride‐rich solutions for fluid resuscitation in brain‐injured patients: a randomised double‐blind pilot study. Critical Care 2013;17(2):R77. [PUBMED: 23601796]
Rowell 2016 {published data only}
Rowell SE, Fair KA, Barbosa RR, Watters JM, Bulger EM, Holcomb JB, et al. The impact of pre‐hospital administration of lactated ringer's solution versus normal saline in patients with traumatic brain injury. Journal of Neurotrauma 2016;33(11):1054‐9. [PUBMED: 26914721]
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Yung M, Letton G, Keeley S. Controlled trial of Hartmann's solution versus 0.9% saline for diabetic ketoacidosis. Journal of Paediatrics and Child Health 2017;53(1):12‐7. [PUBMED: 28070957]
References to ongoing studies:
NCT02721654 {published data only}
NCT02721654. Plasma‐lyte 148® versus saline study (PLUS). clinicaltrials.gov/show/NCT02721654 (first received 29 March 2016).
NCT02835157 {published data only}
NCT02835157. Balanced salt solutions vs. normal saline in children with septic shock. clinicaltrials.gov/show/NCT02835157 (first received 10 August 2005).
NCT02875873 {published data only}
NCT02875873. Study protocol for the balanced solution versus saline in intensive care study (basics): a factorial randomised trial. clinicaltrials.gov/show/NCT02875873 (first received 23 August 2016).
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