Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients

Not Applicable

Completed

• Conditions: Septic Shock; Critical Illness; SIRS
• Interventions: Procedure: Gastroscopy

• Registration Number: NCT01585909
• Lead Sponsor: Medical University of Vienna

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-26
• Primary Completion: 2015-02
• Study Completion: 2015-09
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Septic Shock	Gastroscopy	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
healthy/controls	Gastroscopy	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
SIRS	Gastroscopy	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
mortality (6 months)	6 months after inclusion
ICU mortality	at ICU discharge	only for groups "septic shock" and "SIRS"
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.
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"
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.

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria