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Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Intervention: Vancomycin continuous infusion (Drug); Vancomycin intermittent dosing interval (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Hsin Lin, PharmD, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Hsin Lin, PharmD, Email: hlin13@partners.org

Summary

Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to optimize the dosing of vancomycin for this critically ill population. The most efficacious method of administering vancomycin is debated in the literature. Since vancomycin is associated with slow bactericidal activity, it is important to closely monitor serum concentrations so as to achieve early target serum concentration, particularly when treating aggressive S. aureus infections. One study has shown that vancomycin infused continuously may enable faster and more consistent achievement of a therapeutic serum concentration when compared to intermittent infusion. A faster achievement in the goal serum vancomycin concentration would be a protective factor for intensive care unit mortality in patients with MRSA infection. Currently in the surgical ICU (SICU) of our institute, vancomycin is administered based on a vancomycin dosing nomogram. Less than fifty percent of the ICU patients following this nomogram achieved target vancomycin concentration of 15 after 24 hours. To better achieve target vancomycin concentration in 24 hours, we developed a new vancomycin dosing nomogram with a continuous infusion. The aim is to determine which of the two dosing nomogram is more efficient and safer for SICU patients.

Clinical Details

Official title: Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Frequency of achieving target vancomycin concentration

Secondary outcome:

Incidence of nephrotoxicity

To establish the relationship of vancomycin clearance with renal clearance

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and non-pregnant female > 18 years of age admitted to Surgical ICUs with

suspected infection

- Calculated creatinine clearance > 60ml/min

Exclusion Criteria:

- Age < 18 years

- Allergic to vancomycin

- Calculated creatinine clearance < 60ml/min

- Pregnant

- Vancomycin administration more than 8 hour and less than 24 hour prior to study

enrollment

- Anticipated vancomycin treatment less than 2 days for surgical prophylaxis

Locations and Contacts

Hsin Lin, PharmD, Email: hlin13@partners.org

MGH, Boston, Massachusetts 02116, United States; Recruiting
Lin, Email: hlin13@partners.org
Additional Information

Starting date: September 2013
Last updated: June 2, 2014

Page last updated: August 23, 2015

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