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

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ClinicalTrials.gov Identifier: NCT03806543
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jingyuan,Xu, Southeast University, China

Brief Summary:
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.

Condition or disease Intervention/treatment
Vancomycin 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.

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Study Type : Observational
Actual Enrollment : 165 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Influencing Factors of Vancomycin Trough Level and the Rate Achieving the Target Trough Level in Critically Ill Patients: A Retrospective Observational Study
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Vancomycin
    adult patients treated with intravenous vancomycin in intensive care unit


Primary Outcome Measures :
  1. Rate of patients achieving the target vancomycin trough(15-20mg/L) [ Time Frame: 3 years ]
    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.



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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
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.
Criteria

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

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): NCT03806543


Sponsors and Collaborators
Southeast University, China
Investigators
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Principal Investigator: Jingyuan Xu, PHD. Southeast University

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Responsible Party: Jingyuan,Xu, Principal Investigator, Southeast University, China
ClinicalTrials.gov Identifier: NCT03806543     History of Changes
Other Study ID Numbers: 2018ZDSYLL117-P01
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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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
Anti-Bacterial Agents
Anti-Infective Agents