Clinical trial NCT03776409: Safety and Efficacy of Vancomycin Plus Beta-lactams
Official title: Comparison of the Nephrotoxicity of Vancomycin in Combination With Piperacillin/Tazobactam or Other Beta-lactams in Critically Ill Patients: A Retrospective, Multicenter Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Xi'an Jiaotong University
First posted: 2018-12-14
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically ill patients

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: AKI(acute kidney injury)
timeFrame: from 24 hours after the start of the combination until discharge up to one month
measure: clinical efficacy
timeFrame: from 24 hours after the start of the combination until discharge up to one month
Secondary outcomes:
measure: the length of hospital stay
timeFrame: from hospital admission to discharge up to one month
measure: duration of AKI
timeFrame: the time from AKI onset to resolution of AKI up to one month
measure: onset of AKI
timeFrame: the first occurence of AKI after starting concomitant antimicrobial use up to one month
measure: whether renal function return to baseline or not
timeFrame: from AKI onset to resolution of defined AKI up to one month
measure: major acute kidney events at 30 days (MAKE30)
timeFrame: MAKE30 is assessed 30 days following AKI diagnosis
measure: vancomycin trough value assessment
timeFrame: from hospital admission to discharge up to one month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Yalin Dong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: