Urinary KIM-1 After Vancomycin or Linezolid Administration



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:8/22/2018
Start Date:September 2013
End Date:July 2020
Contact:Marc Scheetz, PharmD, MSc
Email:mscheetz@nmh.org
Phone:312.926.2546

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Novel Urinary Biomarkers in the Detection of Vancomycin Associated Renal Injury

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.

see above

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
We found this trial at
1
site
Chicago, Illinois 60611
Principal Investigator: Marc H Scheetz, PharmD, MSc
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mi
from
Chicago, IL
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