VancomycinNCT03456544
Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China
An observational study of Vancomycin and Staphylococcal Infections, run by Peking University First Hospital at 1 site in China.
Trial summary
The objective of this study was to investigate the current situation of vancomycin (VAN)-associated acute kidney injury (VA-AKI) in China and identify the risk factors for VA-AKI, as well as to comprehensively examine the risk related to concurrent drug use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vancomycin, Staphylococcal Infections, Adverse Effect
- What is being tested?
- Vancomycin
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2018to 31 Dec 2019
- 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: All patients who use vancomycin from all centers.
Who may be able to join
- Using Vancomycin
- ≥18 years old
Who cannot join
- Medical records were incomplete
- Had been diagnosed with stage 5 CKD or were regularly receiving dialysis
- SCr were not being adequately monitored to detect the development of AKI
- Had undergone nephrectomy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Lingyun Ma, 008601066110802, haily618@163.com
About this study
The objective of this study was to investigate the current situation of vancomycin (VAN)-associated acute kidney injury (VA-AKI) in China and identify the risk factors for VA-AKI, as well as to comprehensively examine the risk related to concurrent drug use. Further, the investigators assessed the outcomes of patients who developed VA-AKI and the risk factors for these outcomes. Finally, the investigators aimed to provide suggestions for improving the prevention and treatment of VA-AKI in China.
- Conditions
- Vancomycin, Staphylococcal Infections, Adverse Effect, Acute Kidney Injury, Cross-sectional Study
- Being tested
- Vancomycin
- Medical subject headings
- Staphylococcal Infections, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Patients who have vancomycin associated acute kidney injury will be in the Van-AKI group, and those who don't have vancomycin associated acute kidney injury will be in the none VAN-AKI group.
| Study group | Role | What they receive |
|---|---|---|
| VAN-AKI | Patients who had vancomycin associated acute kidney injury. Receives: Drug: Vancomycin | |
| None VAN-AKI | Patients who didn't have vancomycin associated acute kidney injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancomycin-associated acute kidney injury(VAN-AKI) occuration rate
Measured: 1 year
Secondary outcomes (4)
VAN-AKI detection rate
Measured: 1 year
TDM detction rate
Measured: 1 year
0h Serum creatinine detction rate
Measured: 1 year
48h Serum creatinine detction rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start31 Oct 2018
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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 crossover
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Yimin, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456544
- Sponsor's protocol ID
- 20180122
- Status last verified
- Aug 2019
- First submitted
- 1 Feb 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China
- ClinicalTrials.gov ID
- NCT03456544
- Acronym / sponsor ID
- 20180122
- Conditions
- Vancomycin, Staphylococcal Infections, Adverse Effect, Acute Kidney Injury, Cross-sectional Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 7 Mar 2018 (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 objective of this study was to investigate the current situation of vancomycin (VAN)-associated acute kidney injury (VA-AKI) in China and identify the risk factors for VA-AKI, as well as to comprehensively examine the risk related to concurrent drug use. Further, the investigators assessed the outcomes of patients who developed VA-AKI and the risk factors for these outcomes. Finally, the investigators aimed to provide suggestions for improving the prevention and treatment of VA-AKI in China.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAN-AKI | – | Drug: VancomycinPatients who had vancomycin associated acute kidney injury. |
| None VAN-AKI | – | –Patients who didn't have vancomycin associated acute kidney injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who use vancomycin from all centers.
Key inclusion criteria (2 listed)
- Using Vancomycin
- ≥18 years old
Key exclusion criteria (4 listed)
- Medical records were incomplete
- Had been diagnosed with stage 5 CKD or were regularly receiving dialysis
- SCr were not being adequately monitored to detect the development of AKI
- Had undergone nephrectomy
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 |
|---|---|---|
| VancomycinPatients who have vancomycin associated acute kidney injury will be in the Van-AKI group, and those who don't have vancomycin associated acute kidney injury will be in the none VAN-AKI group. | Drug | VAN-AKI |
Primary outcome
Vancomycin-associated acute kidney injury(VAN-AKI) occuration rate
Time frame: 1 year
4 secondary outcomes
VAN-AKI detection rate
Time frame: 1 year
TDM detction rate
Time frame: 1 year
0h Serum creatinine detction rate
Time frame: 1 year
48h Serum creatinine detction rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vancomycin and Staphylococcal Infections, run by Peking University First Hospital at 1 site in 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingyun Ma (008601066110802, haily618@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancomycin-associated acute kidney injury(VAN-AKI) occuration rate (time frame: 1 year). 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 28 Aug 2019.