Clinical Trial: Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients

Brief Summary: For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.

Detailed Summary:
Sponsor: Henry Ford Health System

Current Primary Outcome: Nephrotoxicity [ Time Frame: Day 1 and daily serum creatinine assessment up to date of discharge ]

Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days.

This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Acute Kidney Injury Network Modified Definition of Nephrotoxicity [ Time Frame: Day 1 and daily serum creatinine assessment up to date of discharge ]

    An abrupt (within 48 hour) reduction in kidney function with one or more of the following 1) Increase in SCr ≥ 0.3 mg/dL 2) Increase SCr ≥ 50% or 3) Decreased urine output (< 0.5 ml/kg/hr x 6 hrs).

    This measure will be reported as proportion of patients with acute kidney injury within each group in relation to the number of patients in each group.

  • Clinical Success [ Time Frame: Daily assessment of signs and symptoms of infection ]

    Clinical success is a composite endpoint of those patients with clinical cure or improvement in clinical signs and symptoms of infection (i.e. SIRS criteria, and microbiology).

    This measure will be reported as the proportion of patients with clinical success in each group compared to the the total number of patients in the group.



Original Secondary Outcome: Same as current

Information By: Henry Ford Health System

Dates:
Date Received: November 14, 2012
Date Started: October 2011
Date Completion:
Last Updated: July 8, 2013
Last Verified: July 2013