Safety and Efficacy of Vancomycin Plus Beta-lactams

NCT03776409 | Completed

• 1 other identifier: XJTU1AF2018LSK-169
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (2)

• AKI(acute kidney injury)

  the incidence of acute kidney injury

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

• clinical efficacy

  microbial eradication

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

Secondary Outcomes (6)

• the length of hospital stay

  from hospital admission to discharge up to one month

• 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

• major acute kidney events at 30 days (MAKE30)

  MAKE30 is assessed 30 days following AKI diagnosis

Study Arms (2)

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

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

Interventions

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 piperacillin/tazobactam

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.

vancomycin plus other beta-lactams

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

critically ill patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Vancomycin; Piperacillin; Tazobactam

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillanic Acid; Sulfones

Study Officials

• Yalin Dong, Ph.D

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 14, 2018
• Study Start: December 12, 2018
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: June 23, 2020

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)