Navegando por Palavras-chave "Estudo clínico"

Agora exibindo 1 - 2 de 2
  • Imagem de Miniatura
    Item
    Acesso aberto (Open Access)
    Remoção de cateteres intravenosos periféricos a cada 96 horas ou segundo indicação clínica: estudo clínico, randômico e de não inferioridade
    (Universidade Federal de São Paulo (UNIFESP), 2018-02-22) Vendramim, Patricia [UNIFESP]; Pedreira, Mavilde da Luz Goncalves [UNIFESP]; Avelar, Ariane Ferreira Machado [UNIFESP]; http://lattes.cnpq.br/8919300907658980; http://lattes.cnpq.br/5901248667753975; http://lattes.cnpq.br/8115630097723963; Universidade Federal de São Paulo (UNIFESP)
    Introduction: Peripheral intravenous catheters (PIC) are widely used in clinical practice for intravenous therapy. Although having many advantages when compared to other types of intravascular access, they are not exempt of complications, and in this study, phlebitis is highlighted. In order to prevent phlebitis, it is practiced, to a substantial extent in the national health institutions, the routine replacement of the PIC device at 72 or 96 hours. Aim: To verify if the PIC replacement as clinically indicated is not inferior to the routine replacement every 96 hours regarding phlebitis occurrence; to compare phlebitis severity, PIC dwell time, and other intravenous therapy complications between the study groups. Method: this is a randomized, controlled, noninferiority clinical trial that recruited patients aged eighteen and older, from two São Paulo City hospitals, after approval of ethical merit and clinical study registry, from November 2015 to August 2016. For the sample calculation, 5% of phlebitis prevalence was used, a significance level of 5%, test power of 80% and noninferiority margin of 3%, sample defined number of patients was 1305. The final study sample was composed of 1319 patients, being 672 (50.9%) patients with PIC replacement as per clinical indication and 647 (49.1%) with PIC replacement every 96 hours. Demographics, clinical and intravenous therapy variables were studied. For the statistical analyzes of the categoric variables, the ChiSquare, Fisher's Exact, Fisher's Exact Generalization tests were used; for the numeric variables, MannWhitney or KruskalWallis (p≤0.005) tests were applied. The KaplanMeier curve was used for the survival analysis. Results: For the demographic variables, it was identified a majority of white elderly patients, with almost the same proportion of males and females, and about 55% presented some degree of overweight or obesity, without significant differences between the groups, except for the type of admission that was predominantly clinical (p=0.025). The 1319 patients used 2747 PIC of vialon from different types, and 119 (9.0%) patients developed phlebitis using 134 (4.9%) PIC, with 89.6% of phlebitis grade 1 and 2. There was no significant differences on phlebitis occurrence, (p=0.162) patients and (p=0.324) PIC. The incidence rate of phlebitis/1000 PICday per patient was 14.9 in the clinically indicated replacement group and 23.8 in the routine every 96 hours replacement group (p = 0.006). The survival analyzes has shown no significant differences (p=0.247) between the groups related to the occurrence of the first phlebitis episode. Regarding the number of inserted PIC, it was observed that almost half of number of patients (46.6%) used one PIC and 42.2 % used 2 to 3 PIC with no differences between the groups (p=0.339). The clinically indicated group presented the higher PIC dwell time average (p<0.001), highlighting pain (p=0.004) and infiltration (p=0.002). Conclusion: The study hypothesis was accepted. The PIC replacement according to clinical manifestations was not inferior to the replacement in accordance to time programmed in 96 hours to phlebitis occurrence. Dwell time and the occurrence of other complications, namely, pain and infiltration were more frequent on PIC replacement as per clinical indication.
  • Imagem de Miniatura
    Item
    Acesso aberto (Open Access)
    Terapia celular na angina refratária (ReACT) envolvendo células tronco autólogas de medula óssea em pacientes sem disfunção ventricular esquerda: um possível papel dos monócitos
    (Universidade Federal de São Paulo (UNIFESP), 2010-01-27) Hossne Junior, Nelson Americo [UNIFESP]; Buffolo, Enio [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Background Autologous bone marrow mononuclear cell (BMMC) transplantation has emerged as a potential therapeutic option for refractory angina patients. Previous studies have shown conflicting myocardium reperfusion results. The present study evaluated safety and efficacy of CellPraxis Refractory Angina Cell Therapy Protocol (ReACT™), in which a specific BMMC formulation was administered as the sole therapy for these patients. Methods The Phase I/IIa Non-controlled, Open label, Clinical Trial, involved eight patients with refractory angina and viable ischemic myocardium, without left ventricular dysfunction and who were not suitable for conventional myocardial revascularization. ReACT™ is a surgical procedure involving a single series of multiple injections (40-90 injections, 0.2 ml each) into ischemic areas of the left ventricle. Primary endpoints were Canadian Cardiovascular Society Angina Classification (CCSAC) improvement at the 18 month follow-up and myocardium ischemic area reduction (assessed by scintigraphic analysis) at the 12 month followup, in correlation with a specific BMMC formulation. Findings Almost all patients presented progressive improvement in angina classification beginning 3 months (p=0.008) post procedure which was sustained at the eighteenth month follow-up (p=0.004), as well as objective myocardium ischemic area reduction at 12 months (decrease of 84.4%, p<0.004). A positive correlation was found between monocyte concentration and CCSAC improvement (r = -0.759, p < 0.05). Interpretation Improvement in Canadian Cardiovascular Society Angina Classification, followed by correlated reduction in scintigraphic myocardium ischemic area strongly suggests neoangiogenesis as the main stem cell action mechanism. The significant correlation between number of monocytes and improvement strongly supports a cell related effect of ReACT™. ReACT™ appeared safe and effective.