Clinical Trial: Concentration of Ertapenem in Colorectal Tissue
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Konzentrationen Von Ertapenem in Kolorektalem Gewebe
Brief Summary: The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem.
Detailed Summary: The purpose of this study is to determine the tissue kinetics of ertapenem in colorectal tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the colon/rectum. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.
Sponsor: University of Ulm
Current Primary Outcome:
- Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V.. [ Time Frame: 3 to 6 hours after a single dose of 1 gram ertapenem I.V.. ]
- Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue [ Time Frame: The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours ]The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours
Original Primary Outcome: Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V.. [ Time Frame: 3 to 6 hours after a single dose of 1 gram ertapenem I.V.. ]
Current Secondary Outcome: Safety Assessment [ Time Frame: 0 to approx. 14 days after admission ]
Original Secondary Outcome: Same as current
Information By: University of Ulm
Dates:
Date Received: September 24, 2007
Date Started: September 2007
Date Completion:
Last Updated: December 16, 2016
Last Verified: December 2016
