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

MRSA - Methicillin Resistant Staphylococcus Aureus Infection Clinical Trial

— CIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786161
• Other study ID #: P 002617
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2013
• Last updated: November 30, 2016
• Start date: September 2013
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• MRSA - Methicillin Resistant Staphylococcus Aureus Infection
• Staphylococcal Infections

Intervention

Drug:
• Vancomycin continuous infusion
Vancomycin 24 hour intravenous continuous infusion
• Vancomycin intermittent dosing interval
Vancomycin intravenous infusion at rate 1000mg/hr

Locations

Country	Name	City	State
United States	MGH	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of achieving target vancomycin concentration		24 hours	Yes
Secondary	Incidence of nephrotoxicity		7 to 10 days	Yes
Secondary	To establish the relationship of vancomycin clearance with renal clearance		7 to 10 days	Yes