Assessment of the risks and benefits of Vancomycin use in patients with infectio

Not Applicable

Recruiting

• Conditions: Critical patients, sepsis, acute kidney injury, dialysis, vancomycin; C12.777.419.780.050; D09.400.420.925; C01.539.757; E05.196.353

• Registration Number: RBR-4zrwtz
• Lead Sponsor: Departamento de Clínica Médica da Faculdade de Medicina de Botucatu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Septic patients older than 18 years using vancomycin for at least 48 hours admitted to 2 intensive care units and 4 wards (clinical and surgical). Patients using vancomycin and requiring acute renal support will be included in an additional vancomycin pharmacokinetic / pharmacodynamic research protocol

Exclusion Criteria

Patients under 18 years old; Pregnant women; stage 5 CKD (creatinine clearance less than 15 mL / min, according to the MDRD formula); Kidney transplant recipients; Patients taking vancomycin for less than 48 hours and those admitted or who progressed with acute kidney injury prior to the start of their use

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Higher incidence of acute kidney injury and higher mortality in the group with toxic levels of vancocinemia evaluated in the period of 1 year. <br>The sample size was calculated considering that unfavorable clinical outcomes (AKI or mortality) will be 20% more prevalent in patients with vancomycin subtherapeutic or toxic levels, alpha error of 0.05 and study power of 80%, being necessary 73 patients in each group, that is, 219 patients.

Secondary Outcome Measures

Name	Time	Method
Rate of removal of vancomycin during dialysis therapy. Quantification of antimicrobials in the biological matrix (plasma) will be performed through high performance liquid chromatography (HPLC) using validated and developed bioanalytical methods.<br>The analytical stage will be carried out from February 2018 until June 2018.