Optimise Dosing of Doripenem in critically ill patients receiving a form of dialysis called Continuous Veno-Venous Haemodialfiltratio
Not Applicable
Completed
- Conditions
- InfectionCritical IllnessAcute Kidney InjuryInfection - Studies of infection and infectious agentsRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12611000195954
- Lead Sponsor
- Royal Brisbane and Women's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Critical illness
- Acute kidney injury
- Receiving continuous venovenous haemodialfiltration
- Clinical indication for doripenem
Exclusion Criteria
- Pregnancy
- Allergy to doripenem
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of pharmacokinetic parameters (volume of distribution and clearance).<br><br>Outcome will be determined using pharmacokinetic analysis of doripenem concentrations in serial blood samples[One 8-hour dosing interval between day 2 and 5 of the antibiotic course];Development of doripenem dose schedule in continuous venovenous haemodialfiltration<br><br>Pharmacokinetic analysis of data will procure a population pharmacokinetic model. Within the software NONMEM (Globomax), we will then perform Monte Carlo Simulations of different doses to confirm which doses of doripenem should be administered to ensure therapeutic antibiotic concentrations.[End of patient enrolment]
- Secondary Outcome Measures
Name Time Method Identification of covariates predictive of altered pharmacokinetics.<br><br>Covariates will be asssessed for statistical significance using a statistical package (SPSS, version 17.0) and subsequently interpreted for clinical relevance by an intensive care physician[End of patient enrolment]