Vancomycin-Associated Nephrotoxicity

Nephrotoxicity Clinical Trial

Official title:

Occurrence and Economic Impact of Nephrotoxicity Associated With Vancomycin Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216540
• Other study ID #: IIS-000184
• Status: Completed
• Start date: November 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2022
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary goal of this study is to determine if there is an association between greater exposure to vancomycin and the development of nephrotoxicity. The secondary goal is to estimate the costs to the hospital associated with these nephrotoxic events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older at time of hospital admission

• Had an absolute neutrophil count of = 1000 cells/mm^3

• Received > 48 hours of intravenous vancomycin therapy

• Had one or more vancomycin trough levels reported within the 96 hours after therapy initiation

• Had a baseline serum creatinine level of < 2.0 mg/dL and baseline creatinine clearance level of = 30 mL/min

Exclusion Criteria:

• Previous diagnosis of cystic fibrosis

Related Conditions & MeSH terms

• Nephrotoxicity

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Cubist Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to nephrotoxicity		within 72 hours post completion of vancomycin therapy
Secondary	Hospital costs		until discharge
Secondary	Length of stay		until discharge