CClinicalTrials.gg
TerminatedNCT02067390Updated Feb 20, 2020

Urinary KIM-1 After Vancomycin or Linezolid Administration

An observational study in Acute Kidney Injury, sponsored by Midwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by Midwestern University · Observational

Why this study was terminated
Slow enrollment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

see above

02

Conditions studied

  • Acute Kidney Injury

Browse trials for

03

In context

Acute Kidney Injury

1,594 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.

This study's enrollment of 5 is below the median of 151 across 772 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Midwestern University is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • Vancomycin

    Vancomycin

  • Linezolid

    Linezolid

06

What researchers measure

Primary outcomes

  1. Urinary KIM-1 concentrations

    Urinary KIM-1 concentrations will be compared between patients receiving vancomycin and linezolid

    Time frame: Urinary levels from day -1 to day +5, clinical outcomes and variables followed for duration of hospitalization

07

Study locations

1 site
  • Northwestern Medicine
    Chicago, Illinois 60611, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02067390
Lead sponsor
Midwestern University
Responsible party
Marc Scheetz (Associate Professor, Midwestern University) — Principal investigator
First posted
Feb 20, 2014
Start date
Sep 2013
Primary completion
May 2019
Completion
May 2019
Last update
Feb 20, 2020

Study contacts

Marc H Scheetz, PharmD
principal investigator · Northwestern Memorial Hospital / Midwestern University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion