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NCT03456544 Clinical Trial

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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03456544
Other study ID # 20180122
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 31, 2018
Est. completion date December 31, 2019

Study information
Verified date August 2019
Source Peking University First Hospital
Contact Lingyun Ma
Phone 008601066110802
Email haily618@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date December 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
China Peking University First Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vancomycin-associated acute kidney injury(VAN-AKI) occuration rate 1 year
Secondary VAN-AKI detection rate 1 year
Secondary TDM detction rate 1 year
Secondary 0h Serum creatinine detction rate 1 year
Secondary 48h Serum creatinine detction rate 1 year
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