Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hospital |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2007 |
| End Date: | April 2009 |
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.
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.
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.
Inclusion Criteria:
- =/> 18 years of age
- Prescribed Continuous Venovenous Hemodialysis (CVVHD) as determined by the primary
physician
- Prescribed daptomycin as determined by the primary physician
- Informed consent granted
Exclusion Criteria:
- < 18 years of age
- Allergy to daptomycin
- Patients being primarily treated with daptomycin for diagnosis of osteomyelitis,
meningitis, or pneumonia without adequate concomitant use of other more effective
antimicrobial agents as daptomycin is not indicated for primary treatment of these
types of infections
- Inability to complete 48 hours of Continuous Venovenous Hemodialysis (CVVHD)
- Concurrent use of other extracorporeal therapies such as Extracorporeal Membrane
Oxygenation (ECMO) or plasmapheresis and intermittent hemodialysis
- Inability to obtain informed consent
- Pregnant and/or breastfeeding women
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