Urinary KIM-1 After Vancomycin or Linezolid Administration

Acute Kidney Injury Clinical Trial

Official title:

Novel Urinary Biomarkers in the Detection of Vancomycin Associated Renal Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02067390
• Other study ID #: STU00075251
• Status: Terminated
• Start date: September 2013
• Est. completion date: May 2019

Study information

• Verified date: February 2020
• Source: Midwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Midwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary KIM-1 concentrations	Urinary KIM-1 concentrations will be compared between patients receiving vancomycin and linezolid	Urinary levels from day -1 to day +5, clinical outcomes and variables followed for duration of hospitalization