Intraosseous vs. Intravenous Vancomycin Administration in Spine Surgery
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Level of Systemic Vancomycin Concentration
研究概览
简要总结
The goal of this research is to learn if injecting the antibiotic vancomycin directly into the bone marrow (intraosseous) or IO) during a lumbar (spinal) fusion surgery, is as effective or better than the standard method of giving it vancomycin through a vein (intravenous) or IV) during lumbar fusion surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing open posterior instrumented spinal fusion (PSIF) or transforaminal lumbar interbody fusion (TLIF)
- •Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study
- •Age Range >18
排除标准
- •Previous spine surgery if surgeon deems it will affect the study
- •BMI > 40
- •Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
- •Inability to administer the IO infusion
- •Refusal to participate
- •Diabetes as defined as uncontrolled A1C > 7.5 and eGFR <59
- •Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo/radiation treatment in last 6 months, medications)
- •No vulnerable populations
研究组 & 干预措施
Intraosseous Vancomycin
Participants in this group will receive other antibiotics according to the Houston Methodist Hospital orthopedic surgeon's standard of care regimen, which typically involves ancef or cefepime being administered in pre-op within 1 hour of the incision. IO Vancomycin will be administered in the OR after incision (500mg in 100-150mL normal saline (NS)), and the injection will be placed into the posterior ilium.
干预措施: Intraosseous Vancomycin (Drug)
Intravenous Vancomycin
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for lumbar fusion patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin), which will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500mL NS).
干预措施: Intravenous Vancomycin (Drug)
结局指标
主要结局
Change in Level of Systemic Vancomycin Concentration
时间窗: Start of skin incision during surgery, Start of closure of skin incision during surgery
The level of vancomycin concentration will be assessed via a blood draw by the anesthesiologist staff.
Level of Vancomycin Concentration in Bone
时间窗: During surgery
Bony tissue samples (Superior Articular Process, Inferior Articular Process, and Lamina) will be taken during surgery to assess levels of vancomycin concentration in the bone.
Level of Vancomycin Concentration in Soft Tissue
时间窗: During surgery
Soft tissue samples (Multifidus muscle, Fat) will be taken during surgery to assess levels of vancomycin concentration in the tissue.
次要结局
- Post-Operative Complication Rates(30 Days Post Surgery, 90 Days Post Surgery)
研究者
Mark Prasarn
Orthopedic Surgeon
The Methodist Hospital Research Institute