Safety and Efficacy of Vancomycin Plus Beta-lactams

Critical Illness Clinical Trial

— SEVPB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776409
• Other study ID #: XJTU1AF2018LSK-169
• Status: Completed
• Start date: December 12, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: December 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

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
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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Second Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	clinical efficacy	microbial eradication	from 24 hours after the start of the combination until discharge up to one month
Secondary	the length of hospital stay		from hospital admission to discharge up to one month
Secondary	duration of AKI		the time from AKI onset to resolution of AKI up to one month
Secondary	onset of AKI		the first occurence of AKI after starting concomitant antimicrobial use up to one month
Secondary	whether renal function return to baseline or not	whether defined AKI was resoluted or not	from AKI onset to resolution of defined AKI up to one month
Secondary	major acute kidney events at 30 days (MAKE30)	MAKE30 is assessed 30 days following AKI diagnosis, which is a composite outcome of death, new dialysis, and worsened renal function.	MAKE30 is assessed 30 days following AKI diagnosis
Secondary	vancomycin trough value assessment	assess the impact of vancomycin exposures on development of AKI	from hospital admission to discharge up to one month