Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.
Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within therapeutic ranges, as previously identified, in critically ill patients with acute renal failure treated with continuous hemodialysis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
8
Daptomcyin 8 mg/kg infused intravenously every 48 hours
University of Michigan University Hospital
Ann Arbor, Michigan, United States
Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis
Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.
Time frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Daptomycin Dose Actually Administered
Time frame: Time of daptomycin administration
Observed Daptomycin Peak Serum Concentration
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.
Time frame: At the end of the daptomycin intravenous infusion (at approximately 30 minutes)
Daptomycin Volume of Distribution at Steady State
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.
Time frame: From time of daptomycin administration to 48 hours post dose
Daptomycin Total Body Clearance
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.
Time frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Daptomycin Half-life
Half-life describes the time it takes for the concentration of the daptomycin in the body to decrease by one half.
Time frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Daptomycin Free Fraction
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.
Time frame: From time of daptomycin administration to 48 hours post dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.