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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456544
Recruitment Status : Unknown
Verified August 2019 by Cui Yimin, Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : March 7, 2018
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Cui Yimin, Peking University First Hospital

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Vancomycin Staphylococcal Infections Adverse Effect Acute Kidney Injury Cross-sectional Study Drug: Vancomycin

Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China
Actual Study Start Date : October 31, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Vancomycin-associated acute kidney injury(VAN-AKI) occuration rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. VAN-AKI detection rate [ Time Frame: 1 year ]
  2. TDM detction rate [ Time Frame: 1 year ]
  3. 0h Serum creatinine detction rate [ Time Frame: 1 year ]
  4. 48h Serum creatinine detction rate [ Time Frame: 1 year ]

Eligibility Criteria
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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
All patients who use vancomycin from all centers.
Criteria

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
Contacts and Locations
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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): NCT03456544


Contacts
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Contact: Lingyun Ma 008601066110802 haily618@163.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Lingyun Ma    008601066110802    haily618@163.com   
Sponsors and Collaborators
Peking University First Hospital
More Information
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Responsible Party: Cui Yimin, Chief pharmacist, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03456544    
Other Study ID Numbers: 20180122
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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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
Additional relevant MeSH terms:
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Staphylococcal Infections
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents