Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)
Information source: University of Michigan
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Daptomycin; Pharmacokinetics; Renal Replacement Therapy; Critical Illness; Intensive Care Units
Intervention: Daptomycin (Drug)
Phase: Phase 4
Status: Suspended
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: Other, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: To quantify daptomycin removal by continuous veno-venous hemodialysis.
Secondary outcome: To characterize the pharmacokinetic parameters of daptomycin in critically ill patients with acute renal failure while being treated with continuous veno-venous hemodialysis.
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 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 CVVHD
- Concurrent use of other extracorporeal therapies such as 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
Ending date: December 2008
Last updated: April 18, 2008
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