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

This study is currently recruiting participants.
Verified September 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Hsin Jung Lin, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01786161
First received: February 4, 2013
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Drug: Vancomycin continuous infusion
Drug: Vancomycin intermittent dosing interval
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Frequency of achieving target vancomycin concentration [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of nephrotoxicity [ Time Frame: 7 to 10 days ] [ Designated as safety issue: Yes ]
  • To establish the relationship of vancomycin clearance with renal clearance [ Time Frame: 7 to 10 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: September 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vancomycin with continuous infusion
continuous 24 hours intravenous infusion
Drug: Vancomycin continuous infusion
Vancomycin 24 hour intravenous continuous infusion
Active Comparator: Vancomycin with intermittent dose interval
infusion rate 1000mg/hr
Drug: Vancomycin intermittent dosing interval
Vancomycin intravenous infusion at rate 1000mg/hr

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01786161

Contacts
Contact: Hsin Lin, PharmD hlin13@partners.org

Locations
United States, Massachusetts
MGH Recruiting
Boston, Massachusetts, United States, 02116
Contact: Lin       hlin13@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Hsin Lin, PharmD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Hsin Jung Lin, PharmD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01786161     History of Changes
Other Study ID Numbers: P 002617
Study First Received: February 4, 2013
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014