NCT01585909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

3.6 years

First QC Date

April 12, 2012

Last Update Submit

August 28, 2017

Conditions

Critical IllnessSeptic ShockSIRS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • activity of the brush border membrane enzyme maltase

    at inclusion

  • activity of the brush border membrane enzyme lactase

    at inclusion

  • Brush border morphology

    at inclusion

  • ICU mortality

    at ICU discharge

  • hospital mortality

    at hospital discharge

  • +1 more secondary outcomes

Study Arms (3)

Septic Shock

OTHER

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

Procedure: Gastroscopy

SIRS

OTHER

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

Procedure: Gastroscopy

healthy/controls

OTHER

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

Procedure: Gastroscopy

Interventions

GastroscopyPROCEDURE

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

SIRSSeptic Shockhealthy/controls

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • PLT \< 50G/l,
  • PT \< 50%,
  • Continuous therapeutic anticoagulation,
  • DIC, st. p. MCI within 14 days,
  • Gastrointestinal perforation,
  • Age \< 18 years,
  • Age \> 80 Years
  • SIRS:
  • 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
  • PLT \< 50G/l,
  • PT \< 50%, continuous therapeutic anticoagulation,
  • DIC, st. p. MCI within 14 days,
  • Gastrointestinal perforation,
  • Age \< 18 years,
  • Age \> 80 Years
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Critical IllnessShock, Septic

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSepsisInfectionsSystemic Inflammatory Response SyndromeInflammationShock

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Ulrike Holzinger, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assoc Prof

Study Record Dates

First Submitted

April 12, 2012

First Posted

April 26, 2012

Study Start

July 1, 2011

Primary Completion

February 1, 2015

Study Completion

September 1, 2015

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

AU(1)