Clinical trial NCT01585909: Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients
Official title: Evaluation of Intestinal Brush Border Enzyme Function in Patients With SIRS and Septic Shock Compared to Control Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Septic Shock
SIRS
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

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

Primary outcomes:
measure: activity of the brush border membrane enzyme intestinal alkaline phosphatase
timeFrame: at inclusion
Secondary outcomes:
measure: activity of the brush border membrane enzyme maltase
timeFrame: at inclusion
measure: activity of the brush border membrane enzyme lactase
timeFrame: at inclusion
measure: Brush border morphology
timeFrame: at inclusion
measure: ICU mortality
timeFrame: at ICU discharge
measure: hospital mortality
timeFrame: at hospital discharge
measure: mortality (6 months)
timeFrame: 6 months after inclusion
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University of Vienna
name: Ulrike Holzinger, MD
role: PRINCIPAL_INVESTIGATOR
References: