Urinary KIM-1 After Vancomycin or Linezolid Administration

Novel Urinary Biomarkers in the Detection of Vancomycin Associated Renal Injury

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02067390

Enrollment

Registered

2014-02-20

Start date

2013-09-30

Completion date

2019-05-31

Last updated

2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results