Evaluation of Intestinal Brush Border Enzyme Function in Patients With SIRS and Septic Shock Compared to Control Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- activity of the brush border membrane enzyme intestinal alkaline phosphatase
研究概览
简要总结
The purpose of this study is to evaluate the role of several enzymes of the gut mucosa in preventing invasion of gastrointestinal bacteria.
详细描述
Systemic Inflammatory Response Syndrome (SIRS), sepsis, septic shock and concomitant multiorgan failure are major causes of morbidity and mortality in intensive care units. During SIRS and septic shock the role of the gut seems to be uncertain. As it serves as an intestinal barrier which allows the symbiotic relationship between man and enteric bacteria, increased gut permeability during critical illness is accused to promote sepsis. Brush border enzymes have the ability to detoxify lipopolysaccharides and prevent bacterial invasion across the gut mucosal barrier. A reduced brush border enzyme function could contribute to the gastrointestinal intolerance in critically ill patients, which is frequently observed. The aim of this study is to assess the influence of SIRS and septic shock on brush border enzyme morphology and function in men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic Shock:
- •Recruitment and inclusion criteria
- •15 mechanically ventilated critically ill patients fulfilling criteria of SIRS (2 symptoms: RR > 20/min, HR > 90/min, Temp. > 38°/< 36°, 12G/l< WBC < 4G/l; assumed or proven infection, persistent hypotension refractory to fluid therapy and need for vasopressors.
- •Time window for inclusion: up to 72h after onset of symptoms
排除标准
- •PLT < 50G/l,
- •PT < 50%,
- •Continuous therapeutic anticoagulation,
- •DIC, st. p. MCI within 14 days,
- •Gastrointestinal perforation,
- •Age < 18 years,
- •Age > 80 Years
- •Recruitment and inclusion criteria
- •15 mechanically ventilated critically ill patients fulfilling criteria of SIRS (2 symptoms: RR > 20/min, HR > 90/min, Temp. > 38°/< 36°, 12G/l < WBC < 4G/l; assumed or proven infection
- •Time window for inclusion: up to 72h after onset of symptoms
- •Exclusion criteria:
- •PLT < 50G/l,
- •PT < 50%, continuous therapeutic anticoagulation,
- •DIC, st. p. MCI within 14 days,
- •Gastrointestinal perforation,
- •Age < 18 years,
- •Age > 80 Years
- •Healthy/controls:
- •15 control subjects will be recruited from the outpatient ward referred to the endoscopy of the Department of Medicine III - Division of Gastroenterology and Hepatology for upper GI-endoscopy because of epigastric pain or reflux symptoms.
- •Inclusion criteria:
- •Signed informed consent
- •Exclusion criteria:
- •Patients with diarrhea of unknown origin, IBD or known celiac disease
- •Age < 18 years
- •Age > 80 Years
- •PLT < 50G/l, PT < 50%
- •Therapeutic oral anticoagulation
研究组 & 干预措施
Septic Shock
Activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as brush border morphology determined from duodenal biopsies in patients with septic shock
干预措施: Gastroscopy (Procedure)
SIRS
Activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as brush border morphology determined from duodenal biopsies in patients with SIRS
干预措施: Gastroscopy (Procedure)
healthy/controls
Activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as brush border morphology determined from duodenal biopsies in patients without SIRS/septic shock
干预措施: Gastroscopy (Procedure)
结局指标
主要结局
activity of the brush border membrane enzyme intestinal alkaline phosphatase
时间窗: at inclusion
Duodenal biopsies will be taken on day 0 (at inclusion) and will be subsequently frozen. Determination of enzyme activity will be done within 28 days.
次要结局
- mortality (6 months)(6 months after inclusion)
- activity of the brush border membrane enzyme maltase(at inclusion)
- activity of the brush border membrane enzyme lactase(at inclusion)
- ICU mortality(at ICU discharge)
- hospital mortality(at hospital discharge)
- Brush border morphology(at inclusion)
研究者
Ulrike Holzinger
MD, Assoc Prof
Medical University of Vienna