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

Evaluation of the safety and efficacy of Vancomycin use in septic patients admitted to the Clinical Hospital of the Botucatu Medical School - UNESP

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-4zrwtz
Enrollment
Unknown
Registered
2018-01-18
Start date
2017-06-01
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

Critical patients, sepsis, acute kidney injury, dialysis, vancomycin

Interventions

One group of 219 patients will be submitted a clinical evaluation of data collected obtained through patient consultation and medical records, from the initial prescription of vancomycin to the end of
Other

Sponsors

Departamento de Clínica Médica da Faculdade de Medicina de Botucatu
Lead Sponsor
Departamento de Clínica Médica da Faculdade de Medicina de Botucatu
Collaborator
Faculdade de Medicina de Botucatu
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Higher incidence of acute kidney injury and higher mortality in the group with toxic levels of vancocinemia evaluated in the period of 1 year. 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

MeasureTime frame
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. The analytical stage will be carried out from February 2018 until June 2018.

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)