Phase 4
N=30
Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients
Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT01027897 ↗Enrolled (actual)
30
Serious AEs
26.7%
Results posted
Sep 2012
Primary outcome: Primary: Volume of Distribution (Vd) — 28.52 liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Doripenem (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume of Distribution (Vd) |
28.52 | — |
| PRIMARY Clearance (CL) |
16.94 | — |
| PRIMARY Elimination Constant (ke) |
1.47 | — |
Summary
The study hypothesis is to measure how the drug doripenem is cleared from the body of critically ill trauma patients. The investigators will measure blood drug concentrations and calculate how much the drug distributes in the body and how fast it is removed from the body. There is little information on how drugs are cleared in critically ill patients and the wrong dose of a drug could make it ineffective. The investigators will use this information to predict the most reasonable dose to treat infections effectively in these patients.
Eligibility Criteria
Inclusion Criteria
- Patients are 18 years of age or older
- Admitted to Emory surgical intensive care unit (ICU) service
- Have a diagnosis of sepsis that requires empiric antimicrobial therapy
- Obtained written informed consent from the patient or a first-degree relative if the patient is unable to give informed consent due to his/her medical condition prior to initiation of any study procedure
Exclusion Criteria
- Surgical ICU length of stay less than 24 hours
- Acute or chronic renal dysfunction (urine output less than 0.5 mL/kg/hr or calculated creatinine clearance of less than 50 mL/min)
- Pregnancy
- Known allergy to beta-lactam antibiotics
- Non-English-speaking patients
Data sourced from ClinicalTrials.gov (NCT01027897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.