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

Comparison of different vancomycin administration regimens in patients with acute kidney injury in hemodialysis therapy: a clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5rcknr
Enrollment
Unknown
Registered
2019-06-04
Start date
2019-04-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis

Interventions

N17.0
Drug
After diagnosis of AKI associated with sepsis and indication of acute renal support, the central venous catheter will be implanted to begin treatment. Patients will be selected to enter the study from

Sponsors

Faculdade de Medicina de Botucatu
Lead Sponsor
Faculdade de Medicina de Botucatu
Collaborator

Eligibility

Age
18 Years to No maximum

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

MeasureTime 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

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

Countries

Brazil

Contacts

Public ContactWelder Zamoner

Departamento de Clínica Médica da Faculdade de Medicina de Botucatu

welderzamoner@gmail.com55-11-997636310

Outcome results

None listed

Source: REBEC (via WHO ICTRP)