Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients

NCT ID: NCT01585909

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-09-30

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.

Conditions

Critical Illness; Septic Shock; SIRS

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Gastroscopy

Intervention Type: PROCEDURE

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

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

Group Type: OTHER

Gastroscopy

Intervention Type: PROCEDURE

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

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

Group Type: OTHER

Gastroscopy

Intervention Type: PROCEDURE

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

Interventions

Gastroscopy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

• Signed informed consent

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:

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Ulrike Holzinger

MD, Assoc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulrike Holzinger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

BBM_septic_shock

Identifier Type: -

Identifier Source: org_study_id