Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry (VCMTDMinCI)
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|ClinicalTrials.gov Identifier: NCT02896218|
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : May 29, 2019
|Condition or disease||Intervention/treatment|
|Critically Ill||Other: Pharmacists consultation|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||400 participants|
|Target Follow-Up Duration:||1 Month|
|Official Title:||Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Pharmacist consulting group
When physicians make the decision that patients need to prescribe vancomycin or need dose adjustment, they will call for a pharmacist consultation. Pharmacists will provide the initial regimen based on PPK methods if applicable, otherwise give the suggestion of the initial dosage according to guidelines. Also, pharmacists will give suggestions on the time of sampling for serum concentration measurement. For dosage adjustment, pharmacists will be informed the results of serum vancomycin concentration, and then make a calculation using Bayesian estimation to determine whether there is a necessity to change the dosing regimen. Pharmacists will follow the patients until they discharge.
Other: Pharmacists consultation
Pharmacists consultation of vancomycin individualized dosing strategy
Usual care group
Empirical use of vancomycin without pharmacists consultation.
- The rate of treatment failure [ Time Frame: 2016-9 to 2018-1 ]
- All cause mortality [ Time Frame: 2016-9 to 2018-1 ]
- Mortality caused by infections [ Time Frame: 2016-9 to 2018-1 ]
- Mortality caused by gram-positive infections [ Time Frame: 2016-9 to 2018-1 ]
- Adverse events related to vancomycin [ Time Frame: 2016-9 to 2018-1 ]
- Nephrotoxicity related to vancomycin [ Time Frame: 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.
- Cost-effectiveness of pharmacist intervention [ Time Frame: 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 [ Time Frame: 2016-9 to 2018-1 ]
- Vancomycin dosage [ Time Frame: -2016-9 to 201 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896218
|Contact: Qinggang Ge, M.D.||email@example.com|
|Contact: Yingying YAN, Ph.D.||firstname.lastname@example.org|
|Peking University Third Hospital||Recruiting|
|Beijing, Beijing, China, 100191|
|Contact: Qinggang Ge, M.D. email@example.com|
|Contact: Yingying Yan, Ph.D. firstname.lastname@example.org|
|Principal Investigator:||Qinggang Ge, M.D.||Peking University Third Hospital|