Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry

• Conditions: Critically Ill
• Interventions: Other: Pharmacists consultation

• Registration Number: NCT02896218
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Study Start: 2016-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-05-29
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pharmacist consulting group	Pharmacists consultation	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.

Primary Outcome Measures

Name	Time	Method
The rate of treatment failure	2016-9 to 2018-1

Secondary Outcome Measures

Name	Time	Method
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.
All cause mortality	2016-9 to 2018-1
Adverse events related to vancomycin	2016-9 to 2018-1
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.
Mortality caused by infections	2016-9 to 2018-1
Mortality caused by gram-positive infections	2016-9 to 2018-1
Duration of using ventilator	2016-9 to 2018-1
Vancomycin dosage	-2016-9 to 201

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China