Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China

August 27, 2019 updated by: Cui Yimin, Peking University First Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

All patients who use vancomycin from all centers.

Description

Inclusion Criteria:

  • Using Vancomycin
  • ≥18 years old

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VAN-AKI
Patients who had vancomycin associated acute kidney injury.
Drug: Vancomycin
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.
None VAN-AKI
Patients who didn't have vancomycin associated acute kidney injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vancomycin-associated acute kidney injury(VAN-AKI) occuration rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
VAN-AKI detection rate
Time Frame: 1 year
1 year
TDM detction rate
Time Frame: 1 year
1 year
0h Serum creatinine detction rate
Time Frame: 1 year
1 year
48h Serum creatinine detction rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 31, 2018

Primary Completion (ANTICIPATED)

October 31, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (ACTUAL)

March 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180122

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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