Effect of Steroids Given Over 24 Hours on Cytokine Release and Urinary Desmosine Levels in Patients Undergoing Bilateral Total Knee Replacement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Decrease in IL6 Level
研究概览
简要总结
Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a major marker of inflammation is known to increase during total joint replacement surgery. IL6 has been found to be elevated postoperatively in patients with hip fractures and has been linked to mental status changes and possibly other complications. It is known to lead to shock and participate in the inflammatory state seen in sepsis. High levels have further been linked to postoperative fever, confusion, symptoms of depression, acute respiratory distress syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found that low dose steroids given in two doses in the initial perioperative period decreased the amount of IL6 released compared to placebo, but this was not sustained past 24 hours.
Desmosine is a stable breakdown product of elastin from lung tissue that can be measured in urine samples. It is considered to be a marker of lung injury and is found to be elevated in patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the investigators have found that urine desmosine levels rise with bilateral total knee replacement compared to unilateral total knee replacement indicating possible lung injury.
Therefore the investigators hypothesize:
Continued low dose steroids given three times over a 24 hour period will:
- Significantly decrease peak IL6 cytokine release during bilateral total knee replacement and maintaining this reduction in IL6 beyond 24 hours.
- Decrease urinary desmosine levels, and hence be protective of lung injury.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Patients scheduled for bilateral total knee replacement
- •Between 50-90 years of age
排除标准
- •Patients on steroid therapy
- •Patients that require stress-dose steroid pre-operatively
- •Patients that smoke
- •Patients that are diabetic
- •Patients younger than 50 or older than 90 years
研究组 & 干预措施
Steroid
Hydrocortisone 100 mg IV Q 8hrs x3
干预措施: Hydrocortisone (Drug)
Control
Saline IV Q8hr x3
干预措施: Saline (Drug)
结局指标
主要结局
Decrease in IL6 Level
时间窗: 24 hours postoperative
次要结局
- Ability to Ambulate(48 hours)
- Blood Glucose(24 hours postoperative)
- In Hospital Infection Rate(Length of hospital stay, an expected average of 5 days)
- Mortality(Length of hospital stay, an expected average of 5 days)
- Desmosine Level(24 hours postoperative)
- Length of Hospital Stay(Length of hospital stay, an expected average of 5 days)