A Clinical Trial of JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition
研究概览
简要总结
We intend, with this study, to prove that blocking the molecular mechanisms whose blockade prevents VIDD in animals, will indeed prevent the development of VIDD in humans as well. We believe that this evidence will serve as the required basis for proceeding with large, ICU-based clinical trial(s) of a drug to prevent VIDD.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing esophagectomy
排除标准
- •Patients with more than mild pulmonary dysfunction
- •Patients with any neuromuscular disease that might compromise diaphragm function
- •Patients with abnormal liver or kidney function
- •Patients taking any immunosuppressant medication (including prednisone) or antifungal medications
- •History of tuberculosis
- •Weight loss of >5% of body weight over previous 6 months
- •Pregnancy
研究组 & 干预措施
Tofacitinib
Patient will receive two days treatment with tofacitinib prior to the surgery.
干预措施: Tofacitinib 10 MG [Xeljanz] (Drug)
Placebo
Patient will receive two days treatment with placebo prior to the surgery.
干预措施: Placebo to match Tofacitinib (Drug)
结局指标
主要结局
Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition
时间窗: 5-6 years
Change in the force deficit that develops between the first and second muscle biopsies in the drug-treated vs. placebo groups
次要结局
- Increase in muscle strength due to JAK inhibition(4-5 years)
研究者
Joseph B. Shrager, MD
Professor
Stanford University