Critical Illness
Conditions
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.
Interventions
DRUGvancomycin plus piperacillin/tazobactam
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.
DRUGvancomycin plus other beta-lactams
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.
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
First Affiliated Hospital Xi'an Jiaotong University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AKI(acute kidney injury) | from 24 hours after the start of the combination until discharge up to one month | the incidence of acute kidney injury |
| clinical efficacy | from 24 hours after the start of the combination until discharge up to one month | microbial eradication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of AKI | the time from AKI onset to resolution of AKI up to one month | — |
| onset of AKI | the first occurence of AKI after starting concomitant antimicrobial use up to one month | — |
| whether renal function return to baseline or not | from AKI onset to resolution of defined AKI up to one month | whether defined AKI was resoluted or not |
| vancomycin trough value assessment | from hospital admission to discharge up to one month | assess the impact of vancomycin exposures on development of AKI |
| major acute kidney events at 30 days (MAKE30) | MAKE30 is assessed 30 days following AKI diagnosis | MAKE30 is assessed 30 days following AKI diagnosis, which is a composite outcome of death, new dialysis, and worsened renal function. |
| the length of hospital stay | from hospital admission to discharge up to one month | — |
Countries
China
Outcome results
None listed