Urinary KIM-1 After Vancomycin or Linezolid Administration

Terminated

• Conditions: Acute Kidney Injury

• Registration Number: NCT02067390
• Lead Sponsor: Midwestern University

Brief Summary

Acute renal injury is a common complication of critical illness. Drug induced renal insult compounds the degree of injury in many patients, and a great deal of research has focused on prevention of this complication. Traditional biomarkers of renal injury like serum creatinine and blood urea nitrogen content fail to consistently predict harm among patients at risk. Kidney Injury Molecule 1 (KIM-1) will be studied as a biomarker of renal injury.

Detailed Description

see above

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-20
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours.
• Eligible patients are already prescribed intravenous vancomycin or linezolid per their primary care providers as a standard of care and dosed in manner that is consistent with current institutional practices. Receipt of these antibiotics is not investigational.

Exclusion Criteria

• Exclusion criteria will include patients who have stage 3or greater Chronic Kidney Disease or who have acute kidney injury prior to the start of intravenous vancomycin therapy, patients that only receive one dose of IV vancomycin or linezolid in total, as well as patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (BMI ≥ 40 kg/m2).
• Additionally, patients will be excluded if they are to receive more than 1 concurrent nephrotoxic medication within the prior 72 hours, have received intravenous contrast within 120 hours before randomization, exhibit baseline hematuria, or baseline proteinuria.
• A list of concurrent nephrotoxins that would exclude patients from the study is provided in Appendix C.
• Age Range: ≥18 years of age, if age > 90 will report as > 90 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urinary KIM-1 concentrations	Urinary levels from day -1 to day +5, clinical outcomes and variables followed for duration of hospitalization	Urinary KIM-1 concentrations will be compared between patients receiving vancomycin and linezolid

Trial Locations

Locations (1)

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States