Safety and Efficacy of Vancomycin Plus Beta-lactams (SEVPB)

Xi'an Jiaotong University

Status: Completed

Conditions: Critical Illness

Treatments: Drug: vancomycin plus piperacillin/tazobactam; Drug: vancomycin plus other beta-lactams

Study type: Observational

Funder types: Other

Identifiers

NCT03776409

XJTU1AF2018LSK-169

Details and patient eligibility

About

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 it is still unknown if 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.

Full description

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.

Enrollment: 700 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

700 participants in 2 patient groups

vancomycin plus piperacillin/tazobactam

Description:

Critically ill patients who received the combination of VAN (vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours during an ICU (intensive care unit) admission, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and PTZ were adjusted based on clinical practice and patient characteristics. This is an observational study without any intervention.

Treatment:

Drug: vancomycin plus piperacillin/tazobactam

vancomycin plus other beta-lactams

Description:

Critically ill patients 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 during an ICU (intensive care unit) admission, 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. This is an observational study without any intervention.

Treatment:

Drug: vancomycin plus other beta-lactams