Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients

Medical University of Vienna

Status: Completed

Conditions: SIRS; Critical Illness; Septic Shock

Treatments: Procedure: Gastroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01585909

BBM_septic_shock

Details and patient eligibility

About

The purpose of this study is to evaluate the role of several enzymes of the gut mucosa in preventing invasion of gastrointestinal bacteria.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Septic Shock

Other group

Description:

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

Treatment:

Procedure: Gastroscopy

SIRS

Other group

Description:

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

Treatment:

Procedure: Gastroscopy

healthy/controls

Other group

Description:

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

Treatment:

Procedure: Gastroscopy