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Completed

NCT Number: NCT03776409

Safety and Efficacy of Vancomycin Plus Beta-lactams

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vancomycin plus piperacillin/tazobactam

Drug

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-lactams

Drug

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.

Primary outcomes

  1. AKI(acute kidney injury)

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

    the incidence of acute kidney injury

  2. clinical efficacy

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

    microbial eradication

Secondary outcomes

  1. the length of hospital stay

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

  2. duration of AKI

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

  3. onset of AKI

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

  4. whether renal function return to baseline or not

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

    whether defined AKI was resoluted or not

  5. major acute kidney events at 30 days (MAKE30)

    Time frame: 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.

  6. vancomycin trough value assessment

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

    assess the impact of vancomycin exposures on development of AKI

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • Second Affiliated Hospital of Xi'an Jiaotong University

Registry information

Official study 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

Acronym: SEVPB

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2018
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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