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

This study has been terminated.
(slow recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01786161
First Posted: February 7, 2013
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hsin Jung Lin, Massachusetts General Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 Hsin Jung Lin, Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of Participants Who Achieved the Target Vancomycin Concentration [ Time Frame: 24 hours ]
    The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV


Secondary Outcome Measures:
  • Time Required to Reach the Therapeutic Levels [ Time Frame: as long as participants are receiving Vancomycin (mean (SD) 9 (3.8) days for continuous, 8.4 (4.1) days for intermittent) ]
    The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV

  • Vancomycin Concentration at 24 Hours [ Time Frame: 24 hours ]
    The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV


Enrollment: 44
Study Start Date: September 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vancomycin with continuous infusion
24 hours continuous 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

Detailed Description:

Early administration of effective antibiotics is the cornerstone of management in septic patients; however, altered pharmacokinetics in critically ill patients has lead to subtherapeutic antibiotic exposure with standard antibiotic dosing and administration. This is further evidenced by low therapeutic target achievement with our intermittent vancomycin dosing nomogram. Administering vancomycin by continuous infusions may lead to achieving a therapeutic concentration and AUC24 more quickly than the administration by intermittent infusions as well as provide a more consistent concentration throughout the dosing period. Therefore, a new vancomycin continuous infusion nomogram was developed to increase the achievement of a goal vancomycin concentration within 24 hours.

We hypothesized that vancomycin administered as continuous infusion would achieve the therapeutic target sooner and more consistently than when administered as an intermittent infusion in critically ill surgical patients. The aims of this study were to determine the dosing differences between continuous (CIV) and intermittent (IIV) dosing in critically ill surgical intensive care unit (SICU) patients with preserved renal function and whether calculated Cockcroft-Gault Creatinine Clearance (CG CrCL) or measured creatinine clearance (CrCL) is a better predictor of vancomycin clearance.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT01786161


Locations
United States, Massachusetts
MGH
Boston, Massachusetts, United States, 02116
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Hsin Lin, PharmD Massachusetts General Hospital
  More Information

Responsible Party: Hsin Jung Lin, PharmD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01786161     History of Changes
Other Study ID Numbers: P 002617
First Submitted: February 4, 2013
First Posted: February 7, 2013
Results First Submitted: March 27, 2017
Results First Posted: May 5, 2017
Last Update Posted: June 7, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents