Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients: A Prospective, Randomized, Open-label, Comparative Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- IL-6, 8, 10, HS-CRP
研究概览
简要总结
The perioperative administration of n-3 fatty acids has been shown to lead to favorable effects on outcome in patients with severe surgical interventions by lowering the magnitude of inflammatory response and by modulating the immune response. To the investigators' knowledge, no study with preoperative administration of intravenous (IV) omega 3 fatty acids as a part of total parenteral nutrition (TPN) or monotherapy with it to demonstrate its effects on inflammatory and immune response has been conducted. So, this study has been planned to judge the inflammatory response of preoperative monotherapy with IV omega 3 fatty acids in elderly patients undergoing valvular surgery considering the hyperinflammation associated with this type of surgery in elderly patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female patients undergoing valvular surgeries
- •Age 18-50 years
- •The patients who give written informed consent
排除标准
- •Refusal to participate in the study
- •Allergy to any of the constituents of nutritional products
- •HIV positive patients, patients with primary diagnosis of hypertriglyceridemia, patients on long term steroid therapy and cycloxygenase inhibitors (more than 3 months)
- •Severe cardiac disease, hepatic disorders (total bilirubin > 1.5 times the upper limit of normal), psychiatric disorders likely to affect compliance, severe hemorrhagic disorders, stroke, embolism
- •Uncontrolled severe renal failure (Serum creatinine > 2 mg/dL) without dialysis/hemofiltration
- •Pregnant or nursing women
- •Participation in any other clinical trial within the last 2 months
研究组 & 干预措施
Omegaven
will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively
干预措施: Omegaven-IV FO (Dietary Supplement)
Without Omegaven
will not receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperativel
结局指标
主要结局
IL-6, 8, 10, HS-CRP
时间窗: 5 days
次要结局
- Infectious complications(5 days)
研究者
Dr. R. Gopinath
Professor
Nizam's Institute of Medical Sciences University, India