The Influencing Factors of Vancomycin Trough Level and the Rate Achieving the Target Trough Level

The Influencing Factors of Vancomycin Trough Level and the Rate Achieving the Target Trough Level in Critically Ill Patients: A Retrospective Observational Study

The aim of this study was to assess factors that may influence vancomycin trough level and the rate achieving the target trough level in critically ill patients.

Study Overview

• Status: Completed
• Conditions: Vancomycin
• Intervention / Treatment: Drug: Vancomycin

Detailed Description

This retrospective observational study included adult patients treated with intravenous vancomycin in intensive care unit of Zhongda Hospital from January 2015 to December 2017. Vancomycin dose was based on international consensus and adjusted according to estimated glomerular filtration rate (eGFR) calculated by the Cockcroft-Gault equation. vancomycin trough level (VTL) was retained at steady state (after the third dose). Linear regression was performed to determine the correlation between factors prior to the first vancomycin dose and VTL. Distribution of VTL and percentage of patients achieving the target trough level (15-20mg/L) was observed in different renal function.

• Study Type: Observational
• Enrollment (Actual): 165

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (age≥18 years) treated with intravenous vancomycin were included. Exclusion criteria were chronic renal dysfunction and acute renal injury patients treated with Renal Replacement therapy, VTL was not retained at steady-state, vancomycin treatment time≤48h, vancomycin dose did not meet study definitions, palliative care.

Description

Inclusion Criteria:

• Adult ICU patients (age≥18 years) treated with intravenous vancomycin were included

Exclusion Criteria:

• Chronic renal dysfunction and acute renal injury patients treated with Renal Replacement therapy
• VTL was not retained at steady-state
• Vancomycin treatment time≤48h
• Vancomycin dose did not meet study definitions
• Palliative care

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients achieving the target vancomycin trough（15-20mg/L）	Vancomycin trough level was retained at steady state (after the third dose). If a patient has multiple measurements of vancomycin trough level, the first measurement is collected.Rate of patients achieving the target trough level (15-20mg/L) was observed.	3 years

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Principal Investigator: Jingyuan Xu, PHD., Southeast university

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: December 22, 2018
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (ACTUAL): January 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 2018ZDSYLL117-P01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No