跳至主要内容
临床试验/NCT01858051
NCT01858051撤回不适用

Bolus vs. Divided Cholecalciferol Dosing to Optimize Perioperative Vitamin D Status for Joint Replacement Surgery

Massachusetts General Hospital2 个研究点 分布在 1 个国家开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in vitamin D status 5 days following supplementation with cholecalciferol

研究概览

简要总结

In the United States, ~1 million elective hip or knee replacement surgeries are performed annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this represents ~25,000 patients at risk of potentially avoidable morbidity following lower extremity joint replacement surgery. Although SSIs only account for 20% of all HAIs, they are a major risk factor for prosthetic joint infections (PJIs). Furthermore, UTIs have also been identified as an independent risk factor for infections of implanted hardware.

In general, the majority of PJIs become apparent within 3 months of hardware implantation, but deep infections may not be evident for up to one year after surgery. Hardware infections result in delayed healing, repeated surgical interventions, and long-term antibiotic therapy. PJIs are associated with an average increase in hospital LOS by 14 days, additional expenditures of up to $50,000 per infected joint, and a doubling of the mortality rate compared to uninfected lower extremity joint replacements.

Recent work from our group suggests that vitamin D insufficiency may be a risk factor for perioperative HAIs. The prevalence of vitamin D insufficiency is approximately 40% in elective joint replacement surgery patients, and perioperative 25(OH)D levels drop 30-40% in the setting of surgical stress, remaining 20% below baseline up to 3 months after surgery. To date, perioperative vitamin D optimization strategies have not been reported. Therefore, our goal is to study the effect of a single (pre-operative) versus a divided (pre-operative and on post-operative day 1) dose of cholecalciferol on perioperative vitamin D status in patients scheduled for elective hip or knee joint replacement surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Age ≥18 years
  • English or Spanish speaking
  • Scheduled for preoperative clinic assessment
  • Scheduled to have elective hip or knee joint replacement surgery
  • Not taking more than 1000 IU of either cholecalciferol or ergocalciferol daily

排除标准

  • Unable to provide consent
  • Inability to comply with study protocol
  • History of anemia (hematocrit <25%)
  • History of renal stones or hypercalcemia
  • Conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis, myeloma)
  • Medications that affect vitamin D metabolism (e.g. anti-epileptics, tuberculosis medication)
  • Already enrolled or planning to enroll in a research study that would conflict with full participation in the current study or confound the observation or interpretation of the study findings

结局指标

主要结局

Change in vitamin D status 5 days following supplementation with cholecalciferol

时间窗: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days

Subjects will receive 150,000 IU or 100,000 IU cholecalciferol (vs. placebo) 3-7 days before surgery during their pre-operative assessment. Vitamin D status on the day of pre-operative assessment will be compared to vitamin D status on the day of surgery. To assess vitamin D status, we will measure serum: 1) 25-hydroxyvitamin D; 2) Parathyroid hormone; 3) Vitamin D binding protein; 4) LL-37; 5) Albumin; and 6) Calcium levels.

次要结局

  • Change in pre-surgical vitamin D status 1 day after surgery(Patients will be followed between the day of surgery and an average duration of 1 day after surgery)
  • Change in pre-surgical vitamin D status 2 weeks after surgery(Patients will be followed between the day of surgery and an average duration of 14 days after surgery)
  • Change in pre-surgical vitamin D status 3 months after surgery(Patients will be followed between the day of surgery and an average of 90 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sadeq A. Quraishi

Assistant Professor of Anaesthesia, Harvard Medical School

Massachusetts General Hospital

研究点 (2)

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