A Randomized, Controlled Study Evaluating the Immune-Modulatory Effects of Perioperative Administration of Arginine Rich Nutritional Supplements With Mass Cytometry in Patient Undergoing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline.
研究概览
简要总结
The primary objective of this study is to characterize the immune-modulatory effects of arginine-rich nutritional supplements in patients undergoing surgery. Numerical and functional changes of all circulating immune cells will be assessed with mass cytometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colon surgery for cancer
- •Patients ≥ 18 and ≤65 years of age
- •Patients willing and able to sign an informed consent form and Health Insurance and Portability Act (HIPAA) authorization and to comply with study procedures
排除标准
- •Patients on immune-suppressant therapy within the last 6 months (e.g. azathioprine or cyclosporine)
- •Patients pretreated (6 months) or currently on chemotherapy for cancer
- •Patients on radiation therapy (within 6 months)
- •Patients on chronic medication with potential immune-modulatory effects (e.g. daily oral morphine-equivalent intake > 30 mg)
- •Patients with metastatic disease
- •Patients with active infectious disease (within 2 months)
- •Patients with significant metabolic disease (e.g. diabetes type I)
- •Patients with clinically significant organ dysfunction including renal and hepatic dysfunction
- •Patients with significant cardiovascular and respiratory comorbidities resulting in impaired function and frailty
- •Patients with autoimmune disease (e.g. lupus)
- •Patients with Hx of substance abuse (e.g., alcoholism, drug dependency)
- •Undernourished patients as indicated by a weight loss >10% during the last 6 months
- •Patients with galactosemia
- •Patients who had undergone previous major abdominal surgery
- •Participation in another clinical trial of an investigational drug or device within the last 30 days prior to the first day of study that, in the investigator's opinion, would create increased risk to the participant or compromise the integrity or either study
- •Other conditions compromising a participant's safety or the integrity of the study
研究组 & 干预措施
Arginine rich nutritional supplement
237 ml of an arginine rich nutritional supplement 4 times a day for the five days preceding surgery.
干预措施: An arginine rich nutritional supplement (Dietary Supplement)
No nutritional supplement
No specific nutritional requirements have to be met in this group.
结局指标
主要结局
Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline.
时间窗: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
The fraction of MDSCs will be quantified.
Functional status change of myeloid-derived suppressor cells (MDSC) from baseline.
时间窗: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
Intracellular phosphorylation events in MDSCs will be quantified.
次要结局
- Impact of surgery on clinical recovery using multiple clinical measures and a validated questionnaire.(Daily for duration of hospital stay, then every 3 days trough postoperative week 5.)
研究者
Martin Angst
Professor of Anesthesia
Stanford University