Impacto da terapia laxativa diária na evolução das disfunções orgânicas em pacientes graves
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Data
2014-10-31
Autores
Azevedo, Rodrigo Palacio de [UNIFESP]
Orientadores
Machado, Flavia Ribeiro [UNIFESP]
Tipo
Tese de doutorado
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A constipação intestinal é uma complicação comumente identificada entre pacientes graves. Recentemente, estudos têm identificado sua presença como um fator de pior prognóstico independente em pacientes graves e sugerido que o seu tratamento pode resultar em melhora de desfechos. O objetivo do presente estudo foi avaliar o impacto da terapia laxativa diária em pacientes graves na intensidade das disfunções orgânicas e em outros desfechos clínicos. Observou-se também a efetividade do protocolo em provocar evacuação diária e os possíveis eventos adversos a ele associados. Tratou-se de estudo de fase II, randomizado, controlado e aberto, incluindo pacientes com mais de 18 anos internados há menos de 72 horas na unidade de terapia intensiva, com previsão de permanecer em ventilação mecânica por pelo menos 72 horas e recebendo via enteral pelo menos 20% do alvo calórico. Foram excluídos pacientes gestantes, com fraturas instáveis, ostomias gastrointestinais, diarreia crônica, doença hepática crônica, doenças neuromusculares, trauma raquimedular, instabilidade hemodinâmica grave, expectativa de sobrevida menor que 24 horas, inclusão prévia no estudo ou aqueles sob cuidados paliativos. Os pacientes foram randomizados (1:1) para receber lactulose e clister visando obter 1 a 2 episódios de evacuação por dia (grupo intervenção) ou receber clister somente após 5 dias sem evacuação (grupo controle). O desfecho primário foi a redução do escore Sequential Organ Failure Assessement (SOFA) no 14o dia. Foram incluídos 44 em cada grupo. Os pacientes do grupo intervenção tiveram um maior taxa de evacuação diária (1,3 ± 0,42 e 0,7 ± 0,56, p < 0,0001), menor tempo para 1a evacuação (14,5 (4,5 a 24,0) horas e 96,0 (50,5 a 127,5) horas, p < 0,0001) e menor percentual de dias sem evacuação (33,1% ± 15,7% e 62,3% ± 24,5%, p < 0,0001). Na análise por intenção de tratar, houve maior redução do SOFA no 14o dia nesse grupo (-4,0 (-6,0 a 0) e -1,0 (-4,0 a 1,0), p = 0,046). Não foram observadas diferenças estatisticamente significativas nos demais desfechos. Pacientes com taxa de evacuação diária menor que 1,0 por dia tiveram menor sobrevida (RR: 3,582, IC95% 1,505 ? 8,525; p < 0,001). Foram observados mais efeitos adversos no grupo intervenção, com maior incidência de diarreia, distensão abdominal e vômitos. Não houve diferença na incidência de eventos adversos graves. Conclui-se que essa estratégia visando promoção de evacuações diárias foi capaz de reduzir a intensidade da disfunção orgânica no 14a dia em pacientes sob ventilação mecânica. Esta redução ocorreu a despeito de aumento na ocorrência de eventos adversos não graves.
Constipation is a common complication among critically ill patients. Recently, studies have identified constipation as an independent prognostic factor in critically ill patients and suggested that its treatment may result in better outcomes. The aim of this study was to assess the effects of a laxative therapy protocol aimed at promoting daily defecation on organ dysfunction in mechanically ventilated patients. We also aimed to evaluate the efficacy of the protocol in promoting daily defecation and the safety of this intervention by assessing its associated adverse events. The study was an phase II, prospective, randomized, controlled, non-blinded clinical trial enrolling mechanically ventilated patients over 18 years of age during the first 72 h after intensive care unit admission who were expected to remain on mechanical ventilation for more than 3 days and who were receiving at least 20% of their target calories as enteral nutrition. We excluded pregnant patients, those with unstable fractures, gastrointestinal ostomy, chronic diarrhea, chronic liver disease, neuromuscular diseases, spinal cord injury, severe hemodynamic instability, survival expectancies of less than 24 h, those under palliative care and those previously included in the study. We randomly assigned patients in a 1:1 ratio to a daily defecation group in which the goal was for the patient to produce 1-2 defecations per day or to a control group in which the absence of defecation was tolerated for up to five days Our primary outcome was the change in Sequential Organ Failure Assessment (SOFA) score at day 14. We enrolled 88 patients. The patients included in the treatment group had a higher defecation rate (1.3 ± 0.42 and 0.7 ± 0.56, p < 0.0001), a lower time to first defecation (14.5 (4.5 to 24.0) hours and 96.0 (50.5 to 127.5) hours, p < 0.0001) and a lower percentage of days without defecation throughout the study (33.1% ± 15.7% and 62.3% ± 24.5%, p < 0.0001). The reduction in SOFA scores was greater in the intervention group. There were no differences in any of the secondary outcomes. Our Cox regression model showed that those patients with a defecation rate of below 1.0 bowel movements/day had a shorter survival time than those with a higher defecation rate. In the intention-to-treat analysis the reduction in SOFA scores on day 14 was greater in the intervention group (-4.0 (-6.0, 0) and -1.0 (-4.0, 1.0), p = 0.046). There were no differences in any of the secondary outcomes. Patients with a defecation rate of below 1.0 bowel movements/day had a shorter survival time (HR: 3.582, CI95% 1.505 – 8.525; p < 0.001). Adverse events were more frequent among the patients in the study group, with higher incidences of diarrhea, abdominal distension and vomiting. The incidence of serious adverse events was not different between the groups. In conclusion, our laxative therapy protocol aiming to produce daily defecation was able to reduce the severity of organ dysfunction after 14 days in mechanically ventilated patients despite a small increase in non-serious adverse events.
Constipation is a common complication among critically ill patients. Recently, studies have identified constipation as an independent prognostic factor in critically ill patients and suggested that its treatment may result in better outcomes. The aim of this study was to assess the effects of a laxative therapy protocol aimed at promoting daily defecation on organ dysfunction in mechanically ventilated patients. We also aimed to evaluate the efficacy of the protocol in promoting daily defecation and the safety of this intervention by assessing its associated adverse events. The study was an phase II, prospective, randomized, controlled, non-blinded clinical trial enrolling mechanically ventilated patients over 18 years of age during the first 72 h after intensive care unit admission who were expected to remain on mechanical ventilation for more than 3 days and who were receiving at least 20% of their target calories as enteral nutrition. We excluded pregnant patients, those with unstable fractures, gastrointestinal ostomy, chronic diarrhea, chronic liver disease, neuromuscular diseases, spinal cord injury, severe hemodynamic instability, survival expectancies of less than 24 h, those under palliative care and those previously included in the study. We randomly assigned patients in a 1:1 ratio to a daily defecation group in which the goal was for the patient to produce 1-2 defecations per day or to a control group in which the absence of defecation was tolerated for up to five days Our primary outcome was the change in Sequential Organ Failure Assessment (SOFA) score at day 14. We enrolled 88 patients. The patients included in the treatment group had a higher defecation rate (1.3 ± 0.42 and 0.7 ± 0.56, p < 0.0001), a lower time to first defecation (14.5 (4.5 to 24.0) hours and 96.0 (50.5 to 127.5) hours, p < 0.0001) and a lower percentage of days without defecation throughout the study (33.1% ± 15.7% and 62.3% ± 24.5%, p < 0.0001). The reduction in SOFA scores was greater in the intervention group. There were no differences in any of the secondary outcomes. Our Cox regression model showed that those patients with a defecation rate of below 1.0 bowel movements/day had a shorter survival time than those with a higher defecation rate. In the intention-to-treat analysis the reduction in SOFA scores on day 14 was greater in the intervention group (-4.0 (-6.0, 0) and -1.0 (-4.0, 1.0), p = 0.046). There were no differences in any of the secondary outcomes. Patients with a defecation rate of below 1.0 bowel movements/day had a shorter survival time (HR: 3.582, CI95% 1.505 – 8.525; p < 0.001). Adverse events were more frequent among the patients in the study group, with higher incidences of diarrhea, abdominal distension and vomiting. The incidence of serious adverse events was not different between the groups. In conclusion, our laxative therapy protocol aiming to produce daily defecation was able to reduce the severity of organ dysfunction after 14 days in mechanically ventilated patients despite a small increase in non-serious adverse events.
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Citação
AZEVEDO, Rodrigo Palacio de. Impacto da terapia laxativa diária na evolução das disfunções orgânicas em pacientes graves. 2014. Tese (Doutorado) - Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP), São Paulo, 2014.