Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)
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|ClinicalTrials.gov Identifier: NCT00663403|
Recruitment Status : Completed
First Posted : April 22, 2008
Results First Posted : August 26, 2010
Last Update Posted : December 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Critically Ill Hemodialysis||Drug: Daptomycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
- Drug: Daptomycin
Daptomcyin 8 mg/kg infused intravenously every 48 hoursOther Name: Cubicin
- Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis [ Time Frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis ]Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.
- Daptomycin Dose Actually Administered [ Time Frame: Time of daptomycin administration ]
- Observed Daptomycin Peak Serum Concentration [ Time Frame: At the end of the daptomycin intravenous infusion (at approximately 30 minutes) ]The maximum concentration of daptomycin in the body after receiving a dose of the drug. This was determined at the end of the daptomycin intravenous infusion at approximately 30 min.
- Daptomycin Volume of Distribution at Steady State [ Time Frame: From time of daptomycin administration to 48 hours post dose ]Volume of distribution quantifies the distribution of daptomycin between the blood and the rest of the body. The greater the volume of distribtion, the greater the extent of daptomycin distribution throughout the body.
- Daptomycin Total Body Clearance [ Time Frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis ]Total body clearance represents the rate at which daptomycin is removed from the body. In patients treated with continuous venovenous hemodialysis, the major pathways of daptomycin removal likely are: removal by continuuous venovenous hemodialysis (transmembrane clearance) and breakdown by the liver.
- Daptomycin Half-life [ Time Frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis ]Half-life describes the time it takes for the concentration of the daptomycin in the body to decrease by one half.
- Daptomycin Free Fraction [ Time Frame: From time of daptomycin administration to 48 hours post dose ]In the body, daptomcyin may be bound to proteins in the blood or it may not be bound to any proteins (also as the "free" component.) Free fraction describes the percent of daptomycin that is unbound or free. The unbound portion of daptomycin is able to kill bacteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663403
|United States, Michigan|
|University of Michigan University Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Bruce A Mueller, PharmD||University of Michigan, College of Pharmacy|