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

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ClinicalTrials.gov Identifier: NCT03776409
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 27, 2018
Sponsor:
Collaborator:
Second Affiliated Hospital Xi'an Jiaotong University
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

Condition or disease Intervention/treatment
Critical Illness Drug: vancomycin plus piperacillin/tazobactam Drug: vancomycin plus other 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.


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Study Type : Observational
Estimated Enrollment : 1458 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
vancomycin plus piperacillin/tazobactam
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.
Drug: vancomycin 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.

vancomycin plus other beta-lactams
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.
Drug: vancomycin 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
critically ill patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776409


Contacts
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Contact: Yalin Dong, Ph.D 86-13891800917 dongyalin@mail.xjtu.edu.cn
Contact: Ying Zhang 86-18710451126 xjtuzy941126@stu.xjtu.edu.cn

Locations
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China, Shaanxi
First Affiliated Hospital of Xian Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Yalin Dong, Ph.D         
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Second Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: Yalin Dong, Ph.D First Affiliated Hospital of Xian Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03776409     History of Changes
Other Study ID Numbers: XJTU1AF2018LSK-169
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vancomycin
Critical Illness
Disease Attributes
Pathologic Processes
Tazobactam
Piperacillin
Piperacillin, Tazobactam Drug Combination
Lactams
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action