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Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Critically Ill; Hemodialysis

Intervention: Daptomycin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Michigan

Official(s) and/or principal investigator(s):
Bruce A Mueller, PharmD, Principal Investigator, Affiliation: University of Michigan, College of Pharmacy

Summary

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.

Clinical Details

Official title: Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis

Secondary outcome:

Daptomycin Dose Actually Administered

Observed Daptomycin Peak Serum Concentration

Daptomycin Volume of Distribution at Steady State

Daptomycin Total Body Clearance

Daptomycin Half-life

Daptomycin Free Fraction

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

University of Michigan University Hospital, Ann Arbor, Michigan 48109, United States
Additional Information

Starting date: February 2007
Last updated: August 27, 2010

Page last updated: August 20, 2015

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