sepsis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: septic patients hospitalized in the intensive care sector of Clinics Hospital of Botucatu Medical School - UNESP; over 18 years old; with AKI and clinical presentation suggestive of acute tubular necrosis (ATN) associated with sepsis; in acute renal support and using vancomycin
Exclusion criteria
Exclusion criteria: pregnant women, patients with AKI of other etiologies; patients who are on chronic renal replacement therapy (dialysis or renal transplantation); patients who have had their dialysis session interrupted for clinical or technical reasons; and patients with serum pre-dialysis seric levels of vancomycin greater than 25 mg/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients will be compared between control groups and interventions for serum concentrations and ratio AUC/MIC before, during and after hemodialysis sessions from the pharmacokinetic approach and PK/PD modeling. The data will be initially analyzed for distribution (Shapiro-Wilk Normality Test W). For the continuous variables, the measures of central tendency, mean and standard deviation will be used for those with normal and median and interquartile distribution for those with non-normal distribution. For the categorical variables will be used the measures of frequency and the Chi-Square Test for comparison between the groups. In the comparison of the groups, for the continuous variables, the Anova MR parametric tests (with post-test Dan, Tuckey or Student Newmar keys) and non-parametric ones, Friedman, and for the categorical variables, Mc Nemar From the univariate analysis, the variables associated with outcomes that present p <0.1 will be used in the Cox regression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recovery of renal function (defined as hemodialysis output) and all-cause death (all mortality) will be analyzed. | — |
Countries
Brazil
Contacts
Departamento de Clínica Médica da Faculdade de Medicina de Botucatu