Critically Ill
Conditions
Keywords
Vancomycin, Critically Ill, Pharmacist, Population Pharmacokinetic, Bayesian Methods
Brief summary
Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods based on observed concentrations. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.
Detailed description
Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Vancomycin use is associated with several adverse events, including nephrotoxicity and ototoxicity. Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. Moreover, the Chinese vancomycin TDM guideline recommended that vancomycin dosage should be administered and adjusted individually based on population pharmacokinetic(PPK) and Bayesian methods. However, there is a gap between clinical practice and the guideline. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods. Pharmacists could provide the vancomycin individualized dosing service by joining the ICU multidisciplinary team. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists. This is a single-center, ambispective cohort study. Patients from the retrospective and prospective cohort will be divided into 2 groups by exposure. The exposure is whether patients received pharmacists' consultation. Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: basic demographics, diagnosis, the initial dosage regimen and adjusted strategy of vancomycin, combined special treatment and outcomes.
Interventions
OTHERPharmacists consultation
Pharmacists consultation of vancomycin individualized dosing strategy
Sponsors
Peking University Third Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Admitted to intensive care unit(ICU), Peking University Third Hospital since JAN 2010. * Receiving vancomycin therapy for 72 hours or more. * Aged ≥ 18 years.
Exclusion criteria
* Administration of vancomycin in non-intravenous access. * Life expectancy of less than 24 hours. * Pregnancy women. * Presence of immunodeficiency. * Presence of hematological disorder. * Written informed consent not obtained in the prospective cohort.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of treatment failure | 2016-9 to 2018-1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events related to vancomycin | 2016-9 to 2018-1 | — |
| Mortality caused by infections | 2016-9 to 2018-1 | — |
| All cause mortality | 2016-9 to 2018-1 | — |
| Mortality caused by gram-positive infections | 2016-9 to 2018-1 | — |
| Cost-effectiveness of pharmacist intervention | 2016-9 to 2018-1 | The outcome is the incremental cost of preventing one treatment failure infection-related mortality or nephrotoxicity. |
| Duration of using ventilator | 2016-9 to 2018-1 | — |
| Vancomycin dosage | -2016-9 to 201 | — |
| Nephrotoxicity related to vancomycin | 2016-9 to 2018-1 | According to KDIGO, AKI is defined by any of the following: * Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours; or * Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days; or * Urine volume \<0.5 mL/kg/h for six hours. All adverse events will be assessed and analyzed with WHO-UMC causality criteria by investigators. Adverse events related to vancomycin, especially nephrotoxicity, will be analyzed. |
Countries
China
Contacts
Primary ContactQinggang Ge, M.D.
Backup ContactYingying YAN, Ph.D.
Outcome results
None listed