Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Acute Physiology and Chronic Health Evaluation II (APACHE II) score
研究概览
简要总结
The occurrence of sepsis in trauma patients is a very serious complication. Identifying trauma patients at high risk of sepsis was not revealed in the latest surviving sepsis campaign in 2016. Several biomarkers have been proposed for early prediction of sepsis in trauma patients as leukocyte anti sedimentation rate (LAR) and the proinflammatory cytokine monocyte chemo attractant protein-1 (MCP-1). Sepsis prophylaxis before occurrence of multi-organ failure still represents a major challenge. Vitamin D and probiotics have antimicrobial, anti-inflammatory and gut microbiota immune modulatory properties.Little is known about the effect of vitamin D and probiotics co-supplementation on the inflammatory response in trauma patients at high risk of sepsis.
Another promising strategy is the use of vitamin C in addition to thiamine. Trauma is associated with increased oxidative stress and vitamin C deficiency. High dose vitamin C is required to restore oxidant-antioxidant balance. Vitamin C and thiamine have shown promising results in treatment of sepsis. Vitamin C possesses anti-inflammatory, endothelial protective and anti-microbial effects. Thiamine is the precursor of thiamine pyrophosphate (TPP), a key enzyme in Krebs cycle.
详细描述
This study will investigate effect of vitamin D and probiotics versus Vitamin C and thiamine on inflammatory response (represented by change in MCP-1 level), Sequential Organ Failure Assessment (SOFA) Score and Acute Physiology and Chronic Health Evaluation II (APACHE II) in trauma patients at high risk of sepsis. Secondary goal is to assess if the predictive ability of MCP-1 plus LAR to determine high risk of sepsis in major trauma intensive care patients and if there is correlation between LAR and MCP-1.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult trauma patients admitted to ICU within 24 hours from trauma onset with injury severity score (ISS) ≥ 16 will be recruited after obtaining informed consent
排除标准
- •• Patients admitted to ICU after time exceeding 24 hours from trauma onset.
- •Patients whose age is less than 18 years.
- •Pregnant female.
- •Breast feeding women.
- •Arrest within 24 hours of admission.
- •Immune deficiency or administration of immune suppressant drugs.
- •Serum calcium greater than or equal to 10 mg/dl or phosphate greater than or equal 6 mg/dl.
- •History of primary parathyroid disease.
- •Metabolic bone disease.
- •Sarcoidosis.
- •End stage renal disease.
- •receiving intermittent renal replacement therapy (RRT).
- •Failure of enteral feeding or any contraindication to enteral administration.
- •Obesity , body mass index (BMI > 35 kg/m2)
- •Known contraindication to vitamin C or thiamine (oxalate nephropathy or known glucose-6-phosphate dehydrogenase deficiency)
研究组 & 干预措施
High risk DP
patients will receive one intramuscular (IM) injection of 400,000 IU of cholecalciferol on day- 1 Also, starting from day 1 and till day 6 (for consequential 6 days), patients will receive lactobacillus probiotics (10 billion colony forming unit) in a dose of 6 sachets per day
干预措施: oral lactobacillus probiotics plus intramuscular cholecalciferol (Drug)
High risk CB
Patients will receive vitamin C plus thiamine starting from day 1 in a dose of 1 gm vitamin C and 200 mg thiamine intravenous 4 times at 12-hour intervals for 48 hours
干预措施: intravenous vitamin C plus thiamine (Drug)
结局指标
主要结局
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
时间窗: 0n the Day 0-Day 6 from onset of trauma
minim 0 maximum 71 Increasing score is associated with increasing risk of ICU mortality
次要结局
- Sequential Organ Failure Assessment (SOFA) score(0n the Day 0-Day 6 from onset of trauma)
- Monocyte chemo attractant protein 1 (MCP-1)(0n the Day 0-Day 6 from onset of trauma)
研究者
maha abou-zeid
lecturer of Anesthesia and Surgical Intensive Care
Mansoura University