VancomycinNCT03806543
The Influencing Factors of Vancomycin Trough Level and the Rate Achieving the Target Trough Level
An observational study of Vancomycin, run by Southeast University, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vancomycin
- What is being tested?
- Vancomycin
- Type of treatment
- Injection or infusion
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult ICU patients (age≥18 years) treated with intravenous vancomycin were included
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Vancomycin
- Being tested
- Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
adult patients treated with intravenous vancomycin in intensive care unit
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VancomycinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Jingyuan Xu, PHD., Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806543
- Sponsor's protocol ID
- 2018ZDSYLL117-P01
- Status last verified
- Jan 2019
- First submitted
- 22 Dec 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03806543
- Acronym / sponsor ID
- 2018ZDSYLL117-P01
- Conditions
- Vancomycin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult ICU patients (age≥18 years) treated with intravenous vancomycin were included
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycinadult patients treated with intravenous vancomycin in intensive care unit | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingyuan Xu, PHD. principal investigator
Southeast University
Questions about this trial
What is this clinical trial studying?
An observational study of Vancomycin, run by Southeast University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients achieving the target vancomycin trough（15-20mg/L） (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.