Safety and Efficacy of Vancomycin Plus Beta-lactams

First Affiliated Hospital Xi'an Jiaotong University700 enrolled

Overview

The combination of vancomycin and piperacillin-tazobactam has been associated with an increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but limited data regarding this association exists in critically ill patients. The objective of this study is to compare AKI and efficacy of vancomycin plus piperacillin-tazobactam or beta-lactams. This is a multicenter, retrospective cohort study. Patients from the retrospective cohort will be divided into 2 groups based on the combination regimen received . Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: basic demographics, diagnosis, concomitant nephrotoxic and other antibiotic medications, serum creatine levels, vancomycin concentrations, and indication for antibiotics.

Study Type

OBSERVATIONAL

Enrollment

700

Conditions

Critical Illness

Interventions

vancomycin plus piperacillin/tazobactamDRUG

Patients in intensive care unit who received the combination of VAN(vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours, had a serum creatinine level measured in the 24-hour of hospital admission.The dosage and frequency of VAN and PTZ was adjusted based on clinical practice and patient characteristics.

vancomycin plus other beta-lactamsDRUG

Patients in intensive care unit who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older, * admitted to intensive care unit * received the combination of vancomycin and beta-lactams for at least 48 hours * had a serum creatinine level measured within 24-hour hospital admission * had at least one VAN level drawn while receiving a combination of study antibiotics Exclusion Criteria: * pregnancy or lactating patients * admission to the intensive care unit during administration or within 72 hours of completing the antibiotics * had end-stage renal disease * died within 48 hours of combination antibiotic therapy initiation

Locations (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

AKI(acute kidney injury)

the incidence of acute kidney injury

Time frame: from 24 hours after the start of the combination until discharge up to one month

clinical efficacy

microbial eradication

Time frame: from 24 hours after the start of the combination until discharge up to one month

Secondary Outcomes

the length of hospital stay

Time frame: from hospital admission to discharge up to one month

duration of AKI

Time frame: the time from AKI onset to resolution of AKI up to one month

onset of AKI

Time frame: the first occurence of AKI after starting concomitant antimicrobial use up to one month

whether renal function return to baseline or not

whether defined AKI was resoluted or not

Time frame: from AKI onset to resolution of defined AKI up to one month

major acute kidney events at 30 days (MAKE30)

MAKE30 is assessed 30 days following AKI diagnosis, which is a composite outcome of death, new dialysis, and worsened renal function.

Time frame: MAKE30 is assessed 30 days following AKI diagnosis

vancomycin trough value assessment

assess the impact of vancomycin exposures on development of AKI

Time frame: from hospital admission to discharge up to one month

Data from ClinicalTrials.gov

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