Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02764359
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
William Payne, CAMC Health System

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 6, 2016
Last Update Posted Date October 9, 2018
Actual Study Start Date  ICMJE August 2016
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
Time to attain therapeutic vancomycin concentrations [ Time Frame: < 7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02764359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
  • Reported adverse events [ Time Frame: 48 hours post initial vancomycin dose ]
    Red Man's syndrome: pruritus and erythematous rash involving the face, neck, and upper torso. Nephrotoxicity: increase in serum creatinine (SCr) by 0.5 mg/dL or 50% from baseline on two consecutive measurements.
  • Examine the pharmacokinetic parameter of elimination rate constant (ke) following the loading vancomycin dose [ Time Frame: 12 hours ]
  • Examine the pharmacokinetic parameter of volume of distribution (Vd) following the loading vancomycin dose [ Time Frame: 12 hours ]
  • Intensive care unit length of stay [ Time Frame: 30 days ]
  • Hospital length of stay [ Time Frame: 30 days ]
  • In-hospital mortality [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens
Official Title  ICMJE Single-Center Prospective Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens
Brief Summary

Obesity alters the movement through the body of several antibiotics, including vancomycin. Based on literature to date, total body weight should be used to determine dosages and shorter dosing intervals may be needed. However, hospitals have different approaches to managing vancomycin in this patient population. The most common example is not exceeding a dose of 2,000mg of vancomycin at one time in these patients. However, some institutions including the Charleston Area Medical Center do not have a set maximum one time dose. To date, a study has not been done comparing two different dosing regimens in obese patients to determine if having a maximum dose cap is beneficial.

This research study is attempting to add to the limited existing body of literature regarding vancomycin dosing in obese patients. The investigators hypothesize that optimizing the initial or loading vancomycin dose that obese patients receive will decrease the time to target concentrations. For this study, obese adult patients will be randomized to receive either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg OR 2) a loading dose of 20 mg/kg with a maximum dose of up to 4,000mg. The study's primary aim is to determine differences in the time needed to achieve target vancomycin concentrations and the occurrence of adverse events.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infection
  • Sepsis
  • Obesity
Intervention  ICMJE Drug: IV vancomycin
IV vancomycin for the treatment of infection. Following the vancomycin loading dose, vancomycin dosing will be at the discretion of the pharmacist and attending physician and will follow standard of care.
Study Arms  ICMJE
  • Experimental: IV Vancomycin loading dose- higher
    IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 4,000mg
    Intervention: Drug: IV vancomycin
  • Experimental: IV Vancomycin loading dose- lower
    IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 2,000mg
    Intervention: Drug: IV vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2016)
128
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients ≥18 years of age who present to the Charleston Area Medical Center-Memorial Hospital Emergency Department
  • Weight >100kg
  • Infection requiring intravenous vancomycin and admission to Charleston Area Medical Center-Memorial Hospital

Exclusion Criteria:

  • Any patient <18 years of age
  • Patients on dialysis or with unstable renal function (a change of >0.5 mg/dL in SCr concentration in patients with a SCr of <2 mg/dL or a 20% change in SCr in patients with a SCr of ≥2 mg/dL)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: William Payne, MD 304-388-6004 Murnau@aol.com
Contact: Adam Crawford, DO 304-388-6004 acrawford@osteo.wvsom.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02764359
Other Study ID Numbers  ICMJE 15-120
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Payne, CAMC Health System
Study Sponsor  ICMJE CAMC Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CAMC Health System
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP