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Urinary KIM-1 After Vancomycin or Linezolid Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02067390
Recruitment Status : Recruiting
First Posted : February 20, 2014
Last Update Posted : August 20, 2018
Information provided by (Responsible Party):
Marc Scheetz, 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.

Condition or disease
Acute Kidney Injury

Detailed Description:
see above

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Urinary Biomarkers in the Detection of Vancomycin Associated Renal Injury
Study Start Date : September 2013
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. Urinary KIM-1 concentrations [ Time Frame: 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

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically/Terminally Ill (ER, ICU)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02067390

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Contact: Marc Scheetz, PharmD, MSc 312.926.2546
Contact: N. J Rhodes, PharmD 312.926.8689

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United States, Illinois
Northwestern Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Scheetz   
Principal Investigator: Marc H Scheetz, PharmD, MSc         
Sponsors and Collaborators
Midwestern University
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Principal Investigator: Marc H Scheetz, PharmD Northwestern Memorial Hospital / Midwestern University

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Responsible Party: Marc Scheetz, Associate Professor, Midwestern University Identifier: NCT02067390     History of Changes
Other Study ID Numbers: STU00075251
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action