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

NCT03456544 | Unknown FDA Drug

• 1 other identifier: 20180122
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Vancomycin-associated acute kidney injury(VAN-AKI) occuration rate

  1 year

Secondary Outcomes (4)

• VAN-AKI detection rate

  1 year

• TDM detction rate

  1 year

• 0h Serum creatinine detction rate

  1 year

• 48h Serum creatinine detction rate

  1 year

Study Arms (2)

VAN-AKI

Patients who had vancomycin associated acute kidney injury.

Drug: Vancomycin

None VAN-AKI

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

Interventions

Vancomycin DRUG

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.

VAN-AKI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who use vancomycin from all centers.

You may qualify if:

• Using Vancomycin
• ≥18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Staphylococcal Infections; Acute Kidney Injury

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Lingyun Ma

CONTACT

008601066110802; haily618@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief pharmacist

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: March 7, 2018
• Study Start: October 31, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CN (1)