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

• Sponsor: Peking University First Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03456544
• Collaborator: (none)
• Enrollment: 10,000
• Location: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 714.5

Study Details

Study Description

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	Phase
Vancomycin; Staphylococcal Infections; Adverse Effect; Acute Kidney Injury; Cross-sectional Study	Drug: Vancomycin

Study Design

• Study Type: Observational
• Anticipated 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: Oct 31, 2018
• Anticipated Primary Completion Date: Oct 31, 2019
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Vancomycin-associated acute kidney injury(VAN-AKI) occuration rate [1 year]

Secondary Outcome Measures

1. VAN-AKI detection rate [1 year]

2. TDM detction rate [1 year]

3. 0h Serum creatinine detction rate [1 year]

4. 48h Serum creatinine detction rate [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Peking University First Hospital	Beijing	Beijing	China	100034

Sponsors and Collaborators

• Peking University First Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cui Yimin, Chief pharmacist, Peking University First Hospital
• ClinicalTrials.gov Identifier: NCT03456544
• Other Study ID Numbers: 20180122
• First Posted: Mar 7, 2018
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• 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: Staphylococcal Infections; Acute Kidney Injury; Wounds and Injuries; Vancomycin

Study Results

No Results Posted as of Aug 28, 2019