Effect of Preoperative Intravenous High Dose Methylprednisolone on Immune Signaling in Patients Scheduled for Total Hip-arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in concentration of plasma-STAT3 (Signal transducer and activator of transcription) from baseline to 48 hours after surgery
研究概览
简要总结
The study evaluates the pathophysiological effects of a single dose Methylprednisolone administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the effect on immune signaling and recovery after surgery.
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 a positive modulation of the immune response and an enhanced recovery.
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.
Hip-arthroplasty surgery and the inflammatory stress response in general affect the potential of recovery. The basic physiological mechanisms behind restoration of recovery after surgery are still unresolved. The many different immune cells involved in the complex signal response enables wound healing and recovery, and the individual immune signal pattern might be able to predict recovery. The effects of glucocorticoids on this immune signal pattern is unknown and calls for further investigation.
The study is to be considered as exploratory. This study is embedded in a primary study registrated as: NCT02445898
For further details please view the EudraCT registration:
EudraCT nr.: 2015-000102-19
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 hip-arthroplasty surgery
- •Speak and understand Danish
- •Have given informed content
排除标准
- •Revision or bilateral hip-arthroplasty surgery
- •General anaesthesia
- •Allergy or intolerance towards Methylprednisolone
- •Local or systemic infection
- •Permanent systemic treatment with steroids within 30 days peroperatively
- •Insulin-dependent diabetes
- •Atrial fibrillation
- •Neurological disease incl. Parkinsons
- •Daily use of hypnotics or sedatives
- •Alcohol abuse >35 units per week
- •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)
Placebo
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 concentration of plasma-STAT3 (Signal transducer and activator of transcription) from baseline to 48 hours after surgery
时间窗: 48 hours after surgery
次要结局
- Change in concentration of plasma-NF-kB (Nuclear factor kB) from baseline to 14 days after surgery(14 days after surgery)
- Change in concentration of plasma-CREB (Adenosine 3',5'-monophosphate response element-binding protein) from baseline to 14 days after surgery(14 days after surgery)
- Change in modified WOMAC (Western Ontario and McMaster Universities Arthritis Index) score from baseline to 28 days after surgery(28 days after surgery)
- Change in concentration of plasma-STAT3 from baseline to 14 days after surgery(14 days after surgery)
- Change in Surgical Recovery Scale score from baseline to 28 days after surgery(28 days after surgery)
研究者
Viktoria Oline Lindberg-Larsen
MD, PhD student
Rigshospitalet, Denmark