Acute Kidney Injury
Conditions
Interventions
This is a randomized, controlled, analytical, quantitative, two-arm, open-label clinical trial. Sixty participants will be included and randomly assigned in a 1:1 ratio, with 30 participants allocated
in cases of hemodynamic instability, it will be repeated every 48 hours. Dosage adjustments in this group will be made based on the serum trough concentration obtained from laboratory analysis. Partic
Sponsors
Casa de Saúde Santa Marcelina Itaquera
Casa de Saúde Santa Marcelina Itaquera
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients hospitalized in infectious disease and internal medicine units; patients aged 18 years or older; patients of any gender or ethnicity; patients with a glomerular filtration rate of 30 mL/min or higher (corresponding to up to stage 3 chronic kidney disease, according to the Brazilian Society of Nephrology [SBN] classification); patients without renal instability prior to the start of therapy (defined as an absolute increase in serum creatinine of at least 0.5 mg/dL or a 50% increase in serum creatinine within 48 hours); patients receiving vancomycin to treat suspected or confirmed infection caused by Staphylococcus spp. or other Gram-positive bacteria; patients requiring vancomycin treatment for at least 3 days; patients receiving concomitant nephrotoxic medications may be included, with the medications used being recorded for analysis.
Exclusion criteria
Exclusion criteria: Patients not admitted to the infectious disease and internal medicine units evaluated in the study; patients who do not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of pharmacokinetic/pharmacodynamic (PK/PD) monitoring based on the 24-hour area under the concentration-time curve (AUC24), compared to the conventional method of monitoring vancomycin trough serum concentrations in reducing the incidence of acute kidney injury. The outcome will be assessed through serial monitoring of patients' renal function during vancomycin treatment, using serum creatinine values ??and acute kidney injury criteria defined as an absolute increase in serum creatinine of at least 0.5 mg/dL or a 50% increase from baseline within 48 hours. The number and percentage of patients developing acute kidney injury in the control and intervention groups will be observed and compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the time to microbiological clearance and vancomycin consumption during the patient follow-up period. The outcome will be assessed by analyzing the results of microbiological cultures performed during treatment and vancomycin utilization records. Observations will include the time (in days) between the start of therapy and the first negative culture, as well as the total duration of vancomycin treatment and the number of doses administered during the follow-up period. | — |
Countries
BR
Contacts
Public ContactAndré Moresi Sonsin
Casa de Saúde Santa Marcelina Itaquera
Outcome results
None listed