Critical Illness, Septic Shock, SIRS
Conditions
Brief summary
The purpose of this study is to evaluate the role of several enzymes of the gut mucosa in preventing invasion of gastrointestinal bacteria.
Detailed description
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.
Interventions
PROCEDUREGastroscopy
When gastroscopy is indicated for clinical reasons, duodenal biopsies to determine the activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as assessing brush border morphology are taken
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
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 SIRS: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| activity of the brush border membrane enzyme intestinal alkaline phosphatase | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| activity of the brush border membrane enzyme lactase | 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. |
| Brush border morphology | 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. |
| activity of the brush border membrane enzyme maltase | 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. |
| hospital mortality | at hospital discharge | only for groups septic shock and SIRS |
| mortality (6 months) | 6 months after inclusion | — |
| ICU mortality | at ICU discharge | only for groups septic shock and SIRS |
Countries
Austria
Outcome results
None listed