Vancomycin-Associated Nephrotoxicity

NCT01216540 | Completed

• 1 other identifier: IIS-000184
• Study Type: observational
• Target: 398
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrotoxicity

Keywords

vancomycin; nephrotoxicity; length of stay; costs

Outcome Measures

Primary Outcomes (1)

• Time to nephrotoxicity

  within 72 hours post completion of vancomycin therapy

Secondary Outcomes (2)

• Hospital costs

  until discharge

• Length of stay

  until discharge

Study Arms (1)

Patients receiving vancomycin

Eligibility Criteria

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

Study Population

A simple random sample of 400 patients treated with greater than 48 hours of intravenous vancomycin exposure during hospitalization during the time period from July 1, 2009 through June 30, 2010

You may qualify if:

• 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

You may not qualify if:

• Previous diagnosis of cystic fibrosis

Sponsors & Collaborators

• University at Buffalo: lead
• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Study Officials

• Jack Brown, PharmD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

• Vanessa Stevens, PhD

  Internal Medicine, Division of Epidemiology, University of Utah School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

US (1)