Urinary KIM-1 After Vancomycin or Linezolid Administration

NCT02067390 | Terminated

• 1 other identifier: STU00075251
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vancomycin

Vancomycin

Linezolid

Linezolid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically/Terminally Ill (ER, ICU)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Midwestern University: lead

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: NONE RETAINED

urine

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Marc H Scheetz, PharmD

  Northwestern Memorial Hospital / Midwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 20, 2014
• Study Start: September 1, 2013
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

US (1)