Effect of Preoperative Intravenous High Dose Methylprednisolone on Complement Activation in Patients Scheduled for Total Knee-arthroplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in plasma and serum Pentraxin-3 concentrations from baseline (before surgery) to 48 hours after surgery
研究概览
简要总结
This study evaluates the pathophysiological effects of a single dose of methylprednisolone administered prior to total knee-arthroplasty surgery. The investigators examine the effect on complement activation.
Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.
The investigators hypothesize that the group receiving methylprednisolone will experience beneficial inhibition of the undesirable parts of the complement activation.
详细描述
The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented.
Anaesthesia and surgery are associated with a dramatic increase in the inflammatory response. The complement system participates in the disposal of products due to inflammatory damage. The complement activation generates proinflammatory mediators which amplifies the tissue damage and the inflammation.
Glucocorticoid administration prior to surgery is thought to effectively reduce the inflammatory response and the activation of the complement system. The effect of glucocorticoids on specific complement markers after surgery is unknown and calls for further investigation.
This study is embedded in a primary study registrated as: NCT02319343
For further details please view the EudraCT registration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthrosis
- •Undergoing total unilateral knee-arthroplasty surgery
- •Speak and understand Danish
- •Have given informed consent
排除标准
- •Revision, bilateral or uni chamber knee-arthroplasty surgery
- •General anaesthesia
- •Allergy or intolerance towards Methylprednisolone
- •Local or systemic infection
- •Permanent systemic treatment with steroids within 30 days preoperatively
- •Insulin-dependent diabetes
- •Active treatment of ulcer within 3 months preoperatively
- •Cancer disease
- •Autoimmune disease incl. rheumatoid arthritis
- •Pregnant or breast feeding women
- •Menopause <1 year
研究组 & 干预措施
Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
干预措施: Methylprednisolone (Drug)
Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride
干预措施: Isotonic Sodium Chloride (Drug)
结局指标
主要结局
Change in plasma and serum Pentraxin-3 concentrations from baseline (before surgery) to 48 hours after surgery
时间窗: baseline to 48 hours
次要结局
- Change in plasma and serum Complement Component 3 concentrations from baseline (before surgery) to 48 hours after surgery(baseline to 48 hours)
- Change in plasma and serum Complement Component 4 concentrations from baseline (before surgery) to 48 hours after surgery(baseline to 48 hours)
- Change in plasma and serum Mannose-binding lectin concentrations from baseline (before surgery) to 48 hours after surgery(baseline to 48 hours)
- Change in plasma and serum Ficolin-1, -2 and -3 concentrations from baseline (before surgery) to 48 hours after surgery(baseline to 48 hours)
- Change in plasma and serum Terminal Complement Complex concentrations from baseline (before surgery) to 48 hours after surgery(baseline to 48 hours)
研究者
Viktoria Oline Lindberg-Larsen
MD, research assistant
Rigshospitalet, Denmark