Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281281
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2006-01-22
Brief Title:
Pharmacokinetics of Vancomycin in Adults Receiving ECMO
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Pharmacokinetics and Posology of Vancomycin in Adults Receiving ECMO
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug toxicity
2 There is limited data on the change of vancomycin pharmacokinetics in patients who need extracorporeal membrane oxygenation ECMO
3 This control trial is to understand
1 whether the pharmacokinetics of vancomycin is influenced by the use ECMO
2 design the most appropriate dose of vancomycin in adult patients using ECMO
2 There is limited data on the change of vancomycin pharmacokinetics in patients who need extracorporeal membrane oxygenation ECMO
3 This control trial is to understand
1 whether the pharmacokinetics of vancomycin is influenced by the use ECMO
2 design the most appropriate dose of vancomycin in adult patients using ECMO
Detailed Description:
1 Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug toxicity
2 Oftentimes it is used in intensive care units ICU for patients who need a life-saving machine for heart and lung failure called extracorporeal membrane oxygenation ECMO
3 There is limited data on the change of vancomycin pharmacokinetics in these patients
4 This is a control trial using ICU patients who need vancomycin but not ECMO as a control to understand
1 whether the pharmacokinetics of vancomycin is influenced by the use ECMO
2 design the most appropriate dose of vancomycin in adult patients using ECMO
5 After the 4th dose of vancomycin blood was drawn at appropriate time spots 1 mL each to determine the time concentration curve and to calculate the pharmacokinetic parameters for 2 groups of patients to determine if there is any difference
2 Oftentimes it is used in intensive care units ICU for patients who need a life-saving machine for heart and lung failure called extracorporeal membrane oxygenation ECMO
3 There is limited data on the change of vancomycin pharmacokinetics in these patients
4 This is a control trial using ICU patients who need vancomycin but not ECMO as a control to understand
1 whether the pharmacokinetics of vancomycin is influenced by the use ECMO
2 design the most appropriate dose of vancomycin in adult patients using ECMO
5 After the 4th dose of vancomycin blood was drawn at appropriate time spots 1 mL each to determine the time concentration curve and to calculate the pharmacokinetic parameters for 2 groups of patients to determine if there is any difference
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None