Status:
TERMINATED
Utility of Vancomycin Loading: A Pharmacokinetic Analysis in Critically Ill Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical research study is to learn if giving a larger than normal "loading dose" of the antibiotic vancomycin before starting standard vancomycin dosing can help patients reach and m...
Detailed Description
The Study Drug: Vancomycin is an antibiotic used to treat serious, life-threatening infections caused by bacteria. Researchers want to find the best and most effective dose and blood-level of the dru...
Eligibility Criteria
Inclusion
- Admission to MD Anderson Cancer Center Surgical Intensive Care Unit (SICU) under the Thoracic Surgery physician group
- Intravenous vancomycin therapy deemed necessary
Exclusion
- Age less than 18 years
- History of hypersensitivity to vancomycin
- Patient weight greater than 150 kg
- Receival of 1 or more doses of the following agents within 72 hours prior to screening: amphotericin B (lipid, liposomal, or conventional formulation), aminoglycosides, foscarnet and/or intravenous contrast dye.
- Prior exposure (within 7 days) to intravenous vancomycin
- Current renal insufficiency defined as baseline Scr \>/= 1.5 mg/dL, or increase in baseline serum creatinine (SCr) by \>/= 0.5 mg/dL within the last 2 days, or estimated creatinine clearance (CrCl) \</= 30 mL/min by Cockcroft-Gault equation.
- Current need for hemodialysis or continuous renal replacement therapy
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01157533
Start Date
June 1 2010
End Date
January 1 2012
Last Update
March 18 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030