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Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

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ClinicalTrials.gov Identifier: NCT04042233
Recruitment Status : Not yet recruiting
First Posted : August 1, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Stephen Incavo MD, The Methodist Hospital System

Tracking Information
First Submitted Date  ICMJE July 30, 2019
First Posted Date  ICMJE August 1, 2019
Last Update Posted Date August 22, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
Systemic Vancomycin level [ Time Frame: 1 year ]
vancomycin blood level at time of initiation of closure.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04042233 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
  • Tissue vancomycin level [ Time Frame: 1 year ]
    at start and end of case.
  • Femur vancomycin level [ Time Frame: 1 year ]
    at start and end of case.
  • Acetabulum vancomycin level [ Time Frame: 1 year ]
    at start and end of case.
  • 30-Day Complications [ Time Frame: From the administration of antibiotics perioperatively to 30 days post op. ]
    Complications 30 days post surgery i.e. infection.
  • 90-Day Complications [ Time Frame: From the administration of antibiotics perioperatively to 90 days post op. ]
    Complications 90 days post surgery i.e. infection
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 Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
Official Title  ICMJE Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
Brief Summary The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.
Detailed Description

Patients are randomized to one of two groups.

GROUP A - Will receive IV antibiotics (cefepime & vancomycin) are started in pre-op approximately 1 hour prior to incision vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 milliliters (mL) normal saline (NS).

GROUP B - Will have IV cefepime started in pre-op within 1 hour of incision. Intraosseous (IO) administration of vancomycin (500mg in 250 milliliters NS) will be administered in the OR after sterile prep and draping has occurred. Injection will take place into the greater trochanter (within a pre-specified region).

Both Groups will be monitored during surgery and immediately post-operatively for adverse injection reactions (i.e. Red Man Syndrome). Both groups will otherwise follow identical post-operative protocols (including post-operative antibiotic administration).

TISSUE SAMPLES Five (5) tissue samples will be taken from each patient, 2 soft tissue samples and 3 bone samples will be taken throughout the course of the procedure.

One blood sample will be taken in both groups intraoperatively at the time of initiation of closure.

These samples will immediately be sent to a lab for analysis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Prosthetic Joint Infection
  • Vancomycin
  • Joint Diseases
Intervention  ICMJE
  • Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS
    500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.
  • Drug: Standard IV administration of vancomycin
    IV antibiotics (cefepime & vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).
Study Arms  ICMJE
  • Active Comparator: IV administration of vancomycin
    Standard IV vancomycin administration protocol.
    Intervention: Drug: Standard IV administration of vancomycin
  • Experimental: IO Vancomycin 500mg in 250 mL NS
    Experimental Intraosseous administration protocol.
    Intervention: Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is undergoing a primary total hip arthroplasty
  • Patient gives informed consent to participate in the study.
  • Age Range >18

Exclusion Criteria:

  • Previous surgery on the hip (including hip scopes)
  • BMI above 35
  • Contraindication to receiving vancomycin or cefepime (allergy, medical issue, etc)
  • Inability to locate the greater trochanter or administer the IO infusion
  • Refusal to participate
  • Diabetes
  • Immunocompromised or immunosuppressed patients (HIV, Hep C, End stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas C Sullivan, B.S. 346-238-1603 tsullivan@houstonmethodist.org
Contact: David Dong, B.S. 713-363-7390 ddong@houstonmethodist.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04042233
Other Study ID Numbers  ICMJE Pro00022651
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stephen Incavo MD, The Methodist Hospital System
Study Sponsor  ICMJE The Methodist Hospital System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen J Incavo, MD The Methodist Hospital System
PRS Account The Methodist Hospital System
Verification Date August 2019

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