Avaliação da eficácia do uso de gentamicina tópica profilática em cateteres tunelizados para hemodiálise: um ensaio clínico randomizado e duplo cego
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Data
2022-10-07
Autores
Caetano, Camille Pereira
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Universidade Estadual Paulista (Unesp)
Resumo
Introdução: As infecções relacionadas ao cateter venoso central (CVC) de hemodiálise (HD) são complicações comuns e que aumentam a morbidade e a mortalidade dos pacientes. As infecções podem ser orifício de saída (IOS), de túnel ou de corrente sanguínea (ICS). Portanto identificar medidas profiláticas e os fatores de risco para infecção é de extrema importância Objetivo: Comparar o uso de gentamicina tópica com o uso de placebo no orifício de saída (OS) de CVC tunelizados preenchidos com a lock terapia em pacientes em HD crônica em relação as taxas de infecção e identificar fatores de risco associados. Metodologia: Ensaio clínico randomizado, duplo cego, que comparou o uso de gentamicina 0,1% versus placebo no OS de CVC tunelizados para HD, que já usavam lock terapia profilática (gentamicina 5mg/ml + cefazolina 10mg/ml + heparina 5000 UI/ml). O total de 91 pacientes foram alocados em dois grupos de modo aleatório: Grupo 1 (G1=controle): Pacientes em uso de placebo em gel no OS; Grupo 2 (G2=intervenção): Paciente em uso de gel de gentamicina a 0,1% no OS. As variáveis categóricas foram representadas pelos percentuais. As variáveis contínuas foram representadas pelas médias e desvios padrão ou medianas e quartis, as de natureza não-paramétrica. Os dois grupos foram comparados quanto às variáveis contínuas e paramétricas utilizando o test t e o teste U de Mann Whitney foram utilizados para os dados contínuos não paramétricos. O teste do Chi-Quadrado foi usado para comparar proporções. Ao final do estudo foi construída a curva de tempo livre de infecção pelo método Kaplan-Meyer e a comparação entre os dois grupos foi realizada utilizando-se o teste de Log rank (valor significativo de p<0,05). Resultado: A média de idade da população estudada foi de 60,4 (+15,3) anos, com predomínio do sexo masculino (60,4%), sendo o diabetes melitos a principal etiologia da DRC (40,7%). Não houve diferença entre os grupos quanto a prevalência de IOS (G1= 30%. G2= 34,1%, p=0,821), de ICS (G1= 22% vs. G1= 17,1%, p=0,60). A densidade de incidência por 1000 cateteres-dia, foi semelhante entre os grupos em relação a IOS e ICS (p=1). Os grupos também foram semelhantes quanto a curva de tempo livre de infecção. O implante do CVC na veia subclávia (VSC) teve maior risco de IOS (p=0,034) e os pacientes com maior mediana de tempo em HD teve maior risco para ICS (p=0,026). Conclusão: Nosso estudo mostrou que a associação da gentamicina a 0,1% tópica no OS não reduziu as complicações infecciosas relacionadas ao CVC tunelizado preenchidos com a lock terapia, quando comparada ao placebo tópico no OS, em pacientes renais crônicos. O implante de CVC na VSC e o maior tempo em HD foram identificados como fatores de risco para infecção.
Background: Hemodialysis (HD) central venous catheter (CVC)-related infections are common complications that increase patient morbidity and mortality. Infections can be exit-site (ESI), tunnel or bloodstream (BSI). Therefore, identifying prophylactic measures and risk factors for infection is extremely important. The aim of the study was to compare the use of topical gentamicin with the use of placebo in the exit-site of tunneled CVCs in patients on chronic HD in relation to infection rates and to identify associated risk factors. Methods: A randomized, double-blind clinical trial that compared the use of 0.1% gentamicin versus placebo in the exit-site of CVC tunneled to HD, who were already using prophylactic lock therapy (gentamicin 5mg/ml + cefazolin 10mg/ml + heparin 5000 IU/ml). A total of 91 patients were randomly allocated into two groups: Group 1 (G1=control): Patients using a placebo gel in the exit-site; Group 2 (G2=intervention): Patient using 0.1% gentamicin gel in exit-site. Categorical variables were represented by percentages. Continuous variables were represented by means and standard deviations or medians and quartiles, those of a non-parametric. The two groups were compared in terms of continuous and parametric variables using the t test and the Mann Whitney U test were used for non-parametric continuous data. The Chi-Square test was used to compare proportions. At the end of the study, the infection-free time curve was constructed using the Kaplan-Meyer method and the comparison between the two groups was performed using the Log rank test (significant value of p<0.05). Results: The mean age of the population studied was 60.4 (+15.3) years, with a predominance of males (60.4%), with diabetes mellitus being the main etiology of chronic kidney disease (40.7%). There was no difference between the groups regarding the prevalence of ESI (G1= 30%. G2= 34.1%, p=0.821), of BSI (G1= 22% vs. G1= 17.1%, p=0.60). The incidence density per 1000 catheters-day was similar between the groups in relation to ESI and BSI. The groups were also similar in terms of the infection-free time curve. CVC implantation in the subclavian vein (VCS) had a higher risk of (p=0.034) and patients with a longer median time on HD had a higher risk for BSI (p=0.026). Conclusion: Our study showed no benefit in the topical use of antibiotics in exit-site to prevent CVC-related infections in HD patients who were already using lock therapy. CVC implantation in the VSC and longer time on HD were identified as risk factors for infection.
Background: Hemodialysis (HD) central venous catheter (CVC)-related infections are common complications that increase patient morbidity and mortality. Infections can be exit-site (ESI), tunnel or bloodstream (BSI). Therefore, identifying prophylactic measures and risk factors for infection is extremely important. The aim of the study was to compare the use of topical gentamicin with the use of placebo in the exit-site of tunneled CVCs in patients on chronic HD in relation to infection rates and to identify associated risk factors. Methods: A randomized, double-blind clinical trial that compared the use of 0.1% gentamicin versus placebo in the exit-site of CVC tunneled to HD, who were already using prophylactic lock therapy (gentamicin 5mg/ml + cefazolin 10mg/ml + heparin 5000 IU/ml). A total of 91 patients were randomly allocated into two groups: Group 1 (G1=control): Patients using a placebo gel in the exit-site; Group 2 (G2=intervention): Patient using 0.1% gentamicin gel in exit-site. Categorical variables were represented by percentages. Continuous variables were represented by means and standard deviations or medians and quartiles, those of a non-parametric. The two groups were compared in terms of continuous and parametric variables using the t test and the Mann Whitney U test were used for non-parametric continuous data. The Chi-Square test was used to compare proportions. At the end of the study, the infection-free time curve was constructed using the Kaplan-Meyer method and the comparison between the two groups was performed using the Log rank test (significant value of p<0.05). Results: The mean age of the population studied was 60.4 (+15.3) years, with a predominance of males (60.4%), with diabetes mellitus being the main etiology of chronic kidney disease (40.7%). There was no difference between the groups regarding the prevalence of ESI (G1= 30%. G2= 34.1%, p=0.821), of BSI (G1= 22% vs. G1= 17.1%, p=0.60). The incidence density per 1000 catheters-day was similar between the groups in relation to ESI and BSI. The groups were also similar in terms of the infection-free time curve. CVC implantation in the subclavian vein (VCS) had a higher risk of (p=0.034) and patients with a longer median time on HD had a higher risk for BSI (p=0.026). Conclusion: Our study showed no benefit in the topical use of antibiotics in exit-site to prevent CVC-related infections in HD patients who were already using lock therapy. CVC implantation in the VSC and longer time on HD were identified as risk factors for infection.
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Palavras-chave
Hemodialysis, Hemodiálise, Cateter tunelizado, Cateteres venosos centrais, Infecções relacionadas a cateter, Prevenção, Tunneled catheter, Central venous catheter, Infection related to access, Prevention