Comparison of different antibiotic vancomycin administration regimens in patients with impaired renal function and need for dialysis

Not Applicable

Recruiting

• Conditions: sepsis; acute kidney injury; nephrotoxicity; N17.0; A41.9; N25.9

• Registration Number: RBR-5rcknr
• Lead Sponsor: Faculdade de Medicina de Botucatu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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/d

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>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<br>From the univariate analysis, the variables associated with outcomes that present p <0.1 will be used in the Cox regression.

Secondary Outcome Measures

Name	Time	Method
Recovery of renal function (defined as hemodialysis output) and all-cause death (all mortality) will be analyzed.