Perioperative Metformin Use in Patients Undergoing Total Joint Replacement Surgery: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of participant enrollment
研究概览
简要总结
The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery.
The primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty.
Secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18-99 years
- •Undergoing total hip or total knee arthroplasty, including elective, primary, and revision surgeries
- •Ability to take oral medication and be willing to adhere to the prescribed metformin regimen regardless of current, past, or no metformin use.
- •Note: Patients with or without type 2 diabetes are considered eligible. (E.g.)
- •Type 2 diabetic on metformin
- •Type 2 diabetic on metformin and other medication, including insulin
- •Type 2 diabetic on medication but not metformin
- •Pre-diabetic
- •Non-diabetic
排除标准
- •Advanced renal insufficiency (glomerular filtration rate (GFR) < 45, or chronic kidney disease (CKD) stage 3B or higher)
- •Advanced liver cirrhosis or failure (Child-Pugh class B or C)
- •Congestive heart failure (New York Heart Association (NYHA) class 3 or 4)
- •Current alcohol abuse within 30 days of surgery (>4 standard servings daily for men, >3 standard servings daily for women)
- •Type 1 diabetes
- •Received contrast dye within 48 hours of surgery
- •Vulnerable populations: Children, pregnant women, neonates, decisionally impaired adults, prisoners
研究组 & 干预措施
Treatment
Oral metformin hydrochloride
干预措施: Metformin (Drug)
Placebo
Placebo tablet
干预措施: Placebo (Other)
结局指标
主要结局
Rate of participant enrollment
时间窗: 3 months
Feasibility defined by an average of four participants per month successfully enrolled and randomized.
Rate of appropriate study drug administration
时间窗: 3 months
Feasibility defined by ≥90% participants receiving 1000mg metformin or placebo daily by day of surgery, assessed via combination of self-report and counting of remaining tablets.
Rate of participant retention to 90-day follow up
时间窗: 3 months
Feasibility defined by ≥90% retention to follow up at 90 days.
Rate of participant adherence to trial intervention per protocol
时间窗: 3 months
Feasibility defined by ≥90% participant adherence to trial intervention per protocol.
次要结局
- 90-day Rate of mortality(3 months)
- 90-day Rate of surgical site infection(3 months)
- Perioperative glycemic variability(3 months)
- Sliding scale insulin utilization(3 months)
- Hospital length of stay(3 months)
- 90-day Rate of periprosthetic joint infection(3 months)
- 90-day rate of readmission(3 months)
研究者
Ryland Kagan
Assistant Professor of Orthopaedics and Rehabilitation
Oregon Health and Science University