Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585909
• Other study ID #: BBM_septic_shock
• Status: Completed
• Phase: N/A
• First received: April 12, 2012
• Last updated: August 28, 2017
• Start date: July 2011
• Est. completion date: September 2015

Study information

• Verified date: August 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Septic Shock
• Shock, Septic
• SIRS

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at inclusion
Secondary	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.	at inclusion
Secondary	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.	at inclusion
Secondary	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.	at inclusion
Secondary	ICU mortality	only for groups "septic shock" and "SIRS"	at ICU discharge
Secondary	hospital mortality	only for groups "septic shock" and "SIRS"	at hospital discharge
Secondary	mortality (6 months)		6 months after inclusion