Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Serum Prothrombin Fragment 1 and 2 (PF 1.2)
研究概览
简要总结
Studies have shown that surgery causes some reactions in your body consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body including the lungs. Corticosteroids are commonly used to treat inflammation and are different from performance enhancing steroids associated with athletics. The purpose of this study is to determine the influence of low dose steroids given 3 times in a 24 hour period on thrombotic markers (markers that are associated with increased risks of clotting, a possible complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized placebo controlled trial patients undergoing total hip replacement.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing unilateral total hip replacement with Drs. Douglas Padgett, Thomas Sculco, or Edwin Su.
- •Patients between the age of 50 and 90
排除标准
- •Patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively
- •Patients who are smokers
- •Patients who have diabetes
- •Patients who are <50 and >90 years of age
- •Patients with history of prior difficulties tolerating corticosteroids
研究组 & 干预措施
Placebo
Control group
干预措施: Placebo (for Prednisone) (Drug)
Prednisone/hydrocortisone
Steroid group will receive the following:
- 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
- 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
干预措施: Prednisone (Drug)
Prednisone/hydrocortisone
Steroid group will receive the following:
- 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
- 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
时间窗: First 24 hours after surgery
Plasmin-a 2 Antiplasmin Complex (PAP)
时间窗: First 24 hours after surgery
次要结局
- Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)(Participants will be followed from the time of surgery until discharge, expected average of 3-5 days)
- Desmosine Level (Marker of Lung Injury)(Participants will be followed from the time of surgery until discharge, expected average of 3-5 days)
- Pain at 3 Months Post-op(3 months postoperatively)