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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03456544
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : May 22, 2018
Information provided by (Responsible Party):
Cui Yimin, Peking University First Hospital

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

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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
Estimated Study Start Date : July 31, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Patients who didn't have vancomycin associated acute kidney injury.

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 ]

Information from the National Library of Medicine

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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.

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

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Responsible Party: Cui Yimin, Chief pharmacist, Peking University First Hospital Identifier: NCT03456544     History of Changes
Other Study ID Numbers: 20180122
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

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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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Wounds and Injuries
Acute Kidney Injury
Staphylococcal Infections
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents