NCT03806543

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

December 22, 2018

Last Update Submit

January 15, 2019

Conditions

Vancomycin

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

VancomycinDRUG

adult patients treated with intravenous vancomycin in intensive care unit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jingyuan Xu, PHD.

    Southeast University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2018

First Posted

January 16, 2019

Study Start

January 1, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

January 16, 2019

Record last verified: 2019-01