Have you or your loved ones been diagnosed with acute kidney injury?

You may be eligible to participate in a acute kidney injury clinical trial.

Have you or your loved ones been diagnosed with acute kidney injury? You may be eligible to participate in a acute kidney injury clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Acute Kidney Injury Clinical Trial in Chicago IL

NCT02067390 | Observational

Have you or your loved ones been diagnosed with acute kidney injury?

You may be eligible to participate in a acute kidney injury clinical trial.

Have you or your loved ones been diagnosed with acute kidney injury? You may be eligible to participate in a acute kidney injury clinical trial.

Terminated

Male & Female

18 Years +

This study has recruited 5 Participants

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.

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Details for the study

Population

Critically/Terminally Ill (ER, ICU)

Brief Title

Urinary KIM-1 After Vancomycin or Linezolid Administration

Official Title

Novel Urinary Biomarkers in the Detection of Vancomycin Associated Renal Injury

Brief Summary

Acute renal injury is a common complication of critical illness. Drug induced renal insult<br /> compounds the degree of injury in many patients, and a great deal of research has focused on<br /> prevention of this complication. Traditional biomarkers of renal injury like serum creatinine<br /> and blood urea nitrogen content fail to consistently predict harm among patients at risk.<br /> Kidney Injury Molecule 1 (KIM-1) will be studied as a biomarker of renal injury.

Detailed Description

see above

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Study Criteria

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