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Completed

NCT Number: NCT01585909

Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gastroscopy

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

Primary outcomes

  1. activity of the brush border membrane enzyme intestinal alkaline phosphatase

    Time frame: 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 outcomes

  1. activity of the brush border membrane enzyme maltase

    Time frame: 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.

  2. activity of the brush border membrane enzyme lactase

    Time frame: 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.

  3. Brush border morphology

    Time frame: 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.

  4. ICU mortality

    Time frame: at ICU discharge

    only for groups "septic shock" and "SIRS"

  5. hospital mortality

    Time frame: at hospital discharge

    only for groups "septic shock" and "SIRS"

  6. mortality (6 months)

    Time frame: 6 months after inclusion

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Evaluation of Intestinal Brush Border Enzyme Function in Patients With SIRS and Septic Shock Compared to Control Patients

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 26, 2012
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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