The Prognostic Impact of Selenium On Critical Surgical Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- mortality rate
研究概览
简要总结
Selenium is an important trace element for human for its multiple roles such as the antioxidant activity. Previous evidences showed that critically ill patients may benefit from selenium supplement but the dose and results are controversial.
Patients after operations for acute abdomen usually suffer from sepsis and stress. The aim of this study is to investigate the efficacy of selenium replacement in critical patients of acute abdomen, to see the impact on prognosis.
详细描述
Acute abdomen is a common surgical emergency and is often the result of peritonitis due to an acute inflammatory process within abdominal cavity. Many of the patients with acute abdomen have severe sepsis and are critically ill that require an emergency surgery.
The mortality rate of such patients are high because these patients usually have a profound pathophysiological dysregulation and multiple organ dysfunction. One of the mechanism of is the loss of anti-oxidative capacity of cells that fail to recover from ischemic-reperfusion injury.
Selenium is an important cofactor that participate in the antioxidant activity of glutathione peroxidase reaction. There are evidences that critically ill patients may benefit from selenium supplement by better outcome and less mortality but the dose and results are still heterogenous and inconclusive.
The aim of this study is to investigate the efficacy of selenium replacement in critical patients of acute abdomen, to see if there is a significant impact on prognosis, and to establish a clinical guide in the future.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intensive care unit (ICU) patients receiving abdominal surgeries for acute abdomen
- •within 48 hours post-operatively
- •stay in ICU for more than 48 hours
- •meets sepsis criteria of Sepsis-3 (2016)
排除标准
- •liver cirrhosis Child-Pugh score B or C
- •breastfeeding or pregnancy
- •allergy yo selenium
- •vegetative status or irreversible diseases with life-expectancy fewer than 28 days
- •End-stage renal disease under dialysis
- •Human immunodeficiency virus infection
- •neutropenia not due to sepsis (granulocyte < 1000/mm3)
- •Heart failure (New York Heart Association class III-IV) or recent myocardial infarction (within 6 weeks)
- •post cardiopulmonary cerebral resuscitation within 4 weeks
- •taking immunosuppressants
- •receiving anti-cancer therapy
- •signed do not resuscitation
- •joined other clinical research
研究组 & 干预措施
low serum selenium with selenium supplement
Patients having low serum selenium with selenium supplement given
干预措施: Selenium Supplement (Drug)
low serum selenium with placebo supplement
Patients having low serum selenium with placebo given
干预措施: normal saline (Drug)
non-low serum selenium with selenium supplement
Patients having normal serum selenium with selenium supplement given
干预措施: Selenium Supplement (Drug)
non-low serum selenium with placebo supplement
Patients having normal serum selenium with placebo given
干预措施: normal saline (Drug)
结局指标
主要结局
mortality rate
时间窗: 30 day
mortality rate in 30 days
次要结局
- hospital length(1 year)
- ventilator length(1 year)
- complication rate(30 days)
- organ failure rate(30 days)