Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Systemic Vancomycin Level - Start of Case
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing a primary total hip arthroplasty
- •Patient gives informed consent to participate in the study.
- •Age Range >18
排除标准
- •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
- •Immunocompromised or immunosuppressed patients (HIV, Hep C, End stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).
研究组 & 干预措施
IV administration of vancomycin
Standard IV vancomycin administration protocol.
干预措施: Standard IV administration of vancomycin (Drug)
IO Vancomycin 500mg in 250 mL NS
Experimental Intraosseous administration protocol.
干预措施: Experimental Intraosseous vancomycin 500mg in 250 mL NS (Drug)
结局指标
主要结局
Systemic Vancomycin Level - Start of Case
时间窗: approximately 10 minutes before incision
vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision.
Systemic Vancomycin Level - End of Case
时间窗: end of surgical case
Vancomycin Concentration of Pulvinar Soft Tissue
时间窗: intraoperative
vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.
Vancomycin Concentration of Intramedullary Bone
时间窗: intraoperative
Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.
次要结局
- Soft Tissue Vancomycin Level - Start of Case(at start of case within 15 minutes after incision)
- Femur Vancomycin Concentration Level(intraoperative)
- Acetabulum Vancomycin Level(intraoperative)
- 30-Day Complications(From the administration of antibiotics perioperatively to 30 days post op.)
- 90-Day Complications(From the administration of antibiotics perioperatively to 90 days post op.)
- Soft Tissue Vancomycin Level - End of Case(right before wound closure is initiated at the end of the case)
研究者
Terry Clyburn
Principal Investigator
The Methodist Hospital Research Institute