Preoperative Single-high Dose Glucocorticoid for Patients Undergoing Hip Fracture Surgery and the Effect on Postoperative Delirium.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
研究概览
简要总结
The Study is a double-blinded, randomized, placebo-controlled trials. The Objective is to investigate the effect of single-high-dose glucocorticoid on surgical stress response and postoperative delirium among Elderly hip Fracture Patients undergoing surgery.
详细描述
Patients with Hip Fracture are exposed for two traumas that can trigger a stress response. The first is the fall that causes the Fracture. The second is the surgery. In this study the intervention is dispensed early in the disease course - as soon as the Fracture has been diagnosed and booked for 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing surgery for hip fracture
- •Informed signed consent
- •Danish speaking
排除标准
- •Allergies towards contents of Solu-Medrol
- •Insulin dependent diabetes
- •In treatment for cancer disease
- •Positive HIV, Hepatitis b or C status
- •Lack of informed consent (eq. Severe dementia, coma, and others)
- •Current treatment with systemic glucocorticoids (pr.os or intravenous) Immunoinflammatory disease (Except topical treated skin disease and respiratory disease)
- •Current Immunosuppressive treatment
- •Unable to participate in CAM-S measurement
- •Peptic ulcera
研究组 & 干预措施
Methylprednisolone sodium succinate
125 mg iv, as single dose, preoperative.
干预措施: methylprednisolone sodium succinate (Drug)
physiological saline
5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi
干预措施: placebo saline (Drug)
结局指标
主要结局
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
时间窗: 3 first post operative days
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
次要结局
- Post operative delirium incidents measured by CAM-S(3 days)
- Patient mobility measured by Cumulated Ambulation Score (CAS)(3 first operative days)
- The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others)(4 days)
- Post operative Fatigue measured with a patient fatigue self-assessment 0-4. (Verbal rating scale) 0=no fatigue, 1=mild, 2 = moderate, 3 = severe, 4 = excruciating (in bed because of fatigue).(3 first postoperative days)
- Psychiatric medications (total amount/use of psychiatric medications)(3 post-OR days)
- Postoperative infections (numbers of patients with postoperative infections)(21 days)
- Length of stay in hospital(21 days)
研究者
Christopher Clemmesen
MD
Hvidovre University Hospital