search
Back to results

Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients

Primary Purpose

Critical Illness, Septic Shock, SIRS

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Gastroscopy
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Critical Illness

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Septic Shock

SIRS

healthy/controls

Arm 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

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

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

Outcomes

Primary Outcome Measures

activity of the brush border membrane enzyme intestinal alkaline phosphatase
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

activity of the brush border membrane enzyme maltase
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 lactase
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
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.
ICU mortality
only for groups "septic shock" and "SIRS"
hospital mortality
only for groups "septic shock" and "SIRS"
mortality (6 months)

Full Information

First Posted
April 12, 2012
Last Updated
August 28, 2017
Sponsor
Medical University of Vienna
search

1. Study Identification

Unique Protocol Identification Number
NCT01585909
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Septic Shock, SIRS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Septic Shock
Arm Type
Other
Arm 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
Arm Title
SIRS
Arm Type
Other
Arm 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
Arm Title
healthy/controls
Arm Type
Other
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Gastroscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
activity of the brush border membrane enzyme intestinal alkaline phosphatase
Description
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.
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
activity of the brush border membrane enzyme maltase
Description
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.
Time Frame
at inclusion
Title
activity of the brush border membrane enzyme lactase
Description
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.
Time Frame
at inclusion
Title
Brush border morphology
Description
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.
Time Frame
at inclusion
Title
ICU mortality
Description
only for groups "septic shock" and "SIRS"
Time Frame
at ICU discharge
Title
hospital mortality
Description
only for groups "septic shock" and "SIRS"
Time Frame
at hospital discharge
Title
mortality (6 months)
Time Frame
6 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Holzinger, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients

We'll reach out to this number within 24 hrs