Effects of Immunonutrition on Biomarkers in Traumatic Brain Injury Patients in Malaysia: a Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Levels of biomarkers
研究概览
简要总结
Background: Head injury is one of the top three diagnosis leading to intensive care unit (ICU) admission in Malaysia. There has been growing interest in using immunonutrition as a mode of modulating the inflammatory response to injury or infection with the aim of improving clinical outcome. The aim of the present study was to evaluate the effect of an immunonutrition on biomarkers (IL-6, glutathione, CRP, total protein and albumin) in traumatic brain injury patients.
Methods: Thirty six patients with head injury admitted to neurosurgical ICU in University Malaya Medical Centre were recruited for this study, over a 6-month period from July 2014 to January 2015. Patients were randomized to receive either an immunonutrition (Group A) or a standard (Group B) enteral feed. Levels of biomarkers were measured at day 1, 5 and 7 of enteral feeding.
Results: Patients in Group A showed significant reduction of IL-6 at day 5 (p<0.001) with concurrent rise in glutathione levels (p= 0.049). Patients in Group A also demonstrated a significant increase of total protein level at the end of the study (day 7).
Conclusion: These findings indicate the potential of immunonutrition reducing cytokines and increasing antioxidant indices in patients with TBI. However, further studies incorporating patient outcomes are needed to determine its overall clinical benefits.
详细描述
Introduction:
In 2014, injury ranked fifth as the most common cause of hospitalisation in Malaysia, with 86% of major trauma patients sustaining injuries to head and neck. It is known that injuries to the brain is among the most likely to result in death and disability. Therefore, it was unsurprising when the Malaysian Registry of Intensive Care reported head injury as one of the top three diagnosis leading to intensive care unit (ICU) admissions with an in-hospital mortality rate of 22.1%. In addition to causing a significant problem in Malaysia, injury related mortality and morbidity also affects countries worldwide and is expected to be a major cause of death and disability by the year 2030.
This study aims to evaluate the effect of a specific immunonutrition, Neomune, on biomarkers (cytokines, acute phase serum proteins and antioxidants) in traumatic brain injury patients. This immune enhancing enteral feed contains arginine, glutamine and omega-3 fatty acid.
Methods:
This study and its protocol was approved by the Medical Ethics Committee University Malaya Medical Center (MEC ID NO: 20143-15). Written informed consent was obtained from patient's next of kin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 78 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission within 48 hours of post traumatic event
- •Moderate to severe head injury (Glasgow Coma Scale 3-12)
- •Requires enteral nutrition.
排除标准
- •Uncontrolled diabetes mellitus
- •Renal or liver dysfunction
- •Severe sepsis with multi organ failure
- •History of significant abdominal or chest injuries requiring major surgery.
结局指标
主要结局
Levels of biomarkers
时间窗: Day 7 of enteral nutirtion
Venous blood was withdrawn from patients to check levels of interleukin-6 (IL-6), glutathione, C-reactive protein (CRP)
次要结局
- Levels of total protein and albumin(Day 1, 5 and 7 of enteral nutrition)
研究者
Dr Loh Pui San
Consultant Anesthesiologist
University of Malaya