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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV administration of vancomycin | Active Comparator | Standard IV vancomycin administration protocol. |
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| IO Vancomycin 500mg in 250 mL NS | Experimental | Experimental Intraosseous administration protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Intraosseous vancomycin 500mg in 250 mL NS | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Vancomycin Level - Start of Case | vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision. | approximately 10 minutes before incision |
| Systemic Vancomycin Level - End of Case | end of surgical case | |
| Vancomycin Concentration of Pulvinar Soft Tissue | vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy. | intraoperative |
| Vancomycin Concentration of Intramedullary Bone | Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy. | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Soft Tissue Vancomycin Level - Start of Case | at start , soft tissue. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography. | at start of case within 15 minutes after incision |
| Femur Vancomycin Concentration Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry A Clyburn, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Administration of Vancomycin | Standard IV vancomycin administration protocol. 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). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2022 | Aug 5, 2024 |
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| Standard IV administration of vancomycin | Drug | 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). |
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Intraoperative femur bone sample measured for vancomycin concentration (ug/mL). Vancomycin tissue concentration measured by high performance liquid chromatography.
| intraoperative |
| Acetabulum Vancomycin Level | Intra-operative Acetabulum bone vancomycin concentrations (ug/mL) measured by high performance liquid chromatography. | intraoperative |
| 30-Day Complications | Complications 30 days post surgery eg. infection. | From the administration of antibiotics perioperatively to 30 days post op. |
| 90-Day Complications | Complications 90 days post surgery eg. infection | From the administration of antibiotics perioperatively to 90 days post op. |
| Soft Tissue Vancomycin Level - End of Case | soft tissue taken at end of case, right before wound closure is initiated. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography. | right before wound closure is initiated at the end of the case |
| IO Vancomycin 500mg in 250 mL NS |
Experimental Intraosseous administration protocol. 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Administration of Vancomycin | Standard IV vancomycin administration protocol. 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). |
| BG001 | IO Vancomycin 500mg in 250 mL NS | Experimental Intraosseous administration protocol. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| The American Society of Anesthesiologists (ASA) physical status classification | ASA I A person in good health. ASA II A mild but well-managed or treated condition ASA III A serious condition that has an impact on a person's overall health. ASA IV A severe condition that's life-threatening. ASA V A life-threatening condition that needs immediate surgery to increase survival odds. ASA VI A deceased person who is an organ donor. | Mean | Standard Deviation | units on a scale |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systemic Vancomycin Level - Start of Case | vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision. | Posted | Mean | Standard Deviation | ug/mL | approximately 10 minutes before incision |
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| Primary | Systemic Vancomycin Level - End of Case | Posted | Mean | Standard Deviation | ug/mL | end of surgical case |
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| Primary | Vancomycin Concentration of Pulvinar Soft Tissue | vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy. | Posted | Mean | Standard Deviation | ug/mL | intraoperative |
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| Primary | Vancomycin Concentration of Intramedullary Bone | Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy. | Posted | Mean | Standard Deviation | ug/mL | intraoperative |
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| Secondary | Soft Tissue Vancomycin Level - Start of Case | at start , soft tissue. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography. | Posted | Mean | Standard Deviation | ug/mL | at start of case within 15 minutes after incision |
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| Secondary | Femur Vancomycin Concentration Level | Intraoperative femur bone sample measured for vancomycin concentration (ug/mL). Vancomycin tissue concentration measured by high performance liquid chromatography. | Posted | Mean | Standard Deviation | ug/mL | intraoperative |
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| Secondary | Acetabulum Vancomycin Level | Intra-operative Acetabulum bone vancomycin concentrations (ug/mL) measured by high performance liquid chromatography. | Posted | Mean | Standard Deviation | ug/mL | intraoperative |
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| Secondary | 30-Day Complications | Complications 30 days post surgery eg. infection. | Posted | Count of Participants | Participants | From the administration of antibiotics perioperatively to 30 days post op. |
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| Secondary | 90-Day Complications | Complications 90 days post surgery eg. infection | Posted | Count of Participants | Participants | From the administration of antibiotics perioperatively to 90 days post op. |
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| Secondary | Soft Tissue Vancomycin Level - End of Case | soft tissue taken at end of case, right before wound closure is initiated. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography. | Posted | Mean | Standard Deviation | ug/mL | right before wound closure is initiated at the end of the case |
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90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Group | IV group | 0 | 10 | 2 | 10 | 1 | 10 |
| EG001 | IO Group | IO | 0 | 10 | 0 | 10 | 0 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | 17 days post-op patient fell off some steps outside their home. Fall was mechanical in nature. Patient unable to weight bear afterwards. XR showed Vancouver B2 fracture. Patient underwent revision THA. After careful review, deemed unrelated AE. |
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| Rectal Bleeding | Gastrointestinal disorders | Systematic Assessment | Patient went to ED for rectal bleeding. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| serosanguinous drainag | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient had small part of distal incision with serosanguinous drainage 8 days post-op. By day 16 day post-op) the incision had stopped draining w/ no overlying erythema etc at any point. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Sullivan | Houston Methodist Hospital | 2817254460 | tsullivan@houstonmethodist.org |
| Prot_001.pdf |
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| ID | Term |
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| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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