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The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care (ENTERIC) Study (ENTERIC)

Primary Purpose

Critical Illness, Malabsorption Syndromes

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Early jejunal feeding (using frictional NJ tube)
Standard feeding (using nasogastric [NG] tube)
Sponsored by
Bayside Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring Mechanically-ventilated, medical-surgical critically ill patients, reduced gastric motility

Eligibility Criteria

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

Inclusion Criteria: ICU patients are eligible for enrolment if they meet all of the following: Age > 18 years old In ICU for < 48 hours prior to enrolment Receiving invasive mechanical ventilation (through an endotracheal tube or tracheostomy, but NOT a facemask) with an anticipated need for > 48 hours of mechanical ventilation Receiving a continuous infusion of any one of: morphine > 2 mg/hour, fentanyl > 20 mcg/hour, or pethidine > 20 mg/hour Either a single GRV > 150 mls (whilst receiving EN via a NG tube) or nasogastric drainage > 500 mls over 12 hours (whether receiving EN or not) Exclusion Criteria: Patients will be ineligible for enrolment if they meet any of the following: Previous or recent surgery which has altered the anatomy of the upper gastrointestinal tract (eg. oesophagectomy, gastrectomy, any gastric anastomosis surgery, gastroplasty, pyloroplasty, pancreaticoduodenectomy [Whipple's procedure]) Known gastric malignancy Known oesophageal varices Current admission for peptic ulceration Current mechanical bowel obstruction Current gastrostomy, jejunostomy, or surgically-placed enteral tube in situ Contraindication to the use of the nose and mouth for enteral tube insertion (eg. recent facial trauma or surgery) Receiving nutritional support prior to ICU admission Severe coagulopathy (defined by platelet count < 20 and/or international normalized ratio [INR] > 4.0)

Sites / Locations

  • Alfred Hospital

Outcomes

Primary Outcome Measures

The amount of EN delivered during the Intensive Care Unit (ICU) stay

Secondary Outcome Measures

Amount of EN delivered during the first 10 days of the study
Daily cumulative proportion of EN delivered
Ventilator-associated pneumonia rate
Duration of mechanical ventilation
Duration of hospitalisation
Mortality at hospital discharge
Success rate of placement into both the small bowel, generally, and the jejunum, specifically
Complication rates (as compared to the nasogastric tube)

Full Information

First Posted
September 12, 2005
Last Updated
February 23, 2007
Sponsor
Bayside Health
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1. Study Identification

Unique Protocol Identification Number
NCT00163813
Brief Title
The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care (ENTERIC) Study
Acronym
ENTERIC
Official Title
The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bayside Health

4. Oversight

5. Study Description

Brief Summary
This is a multi-centre randomised controlled trial comparing early jejunal feeding (using a frictional nasojejunal [NJ] tube) and standard feeding in critical illness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Malabsorption Syndromes
Keywords
Mechanically-ventilated, medical-surgical critically ill patients, reduced gastric motility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Early jejunal feeding (using frictional NJ tube)
Intervention Type
Procedure
Intervention Name(s)
Standard feeding (using nasogastric [NG] tube)
Primary Outcome Measure Information:
Title
The amount of EN delivered during the Intensive Care Unit (ICU) stay
Secondary Outcome Measure Information:
Title
Amount of EN delivered during the first 10 days of the study
Title
Daily cumulative proportion of EN delivered
Title
Ventilator-associated pneumonia rate
Title
Duration of mechanical ventilation
Title
Duration of hospitalisation
Title
Mortality at hospital discharge
Title
Success rate of placement into both the small bowel, generally, and the jejunum, specifically
Title
Complication rates (as compared to the nasogastric tube)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICU patients are eligible for enrolment if they meet all of the following: Age > 18 years old In ICU for < 48 hours prior to enrolment Receiving invasive mechanical ventilation (through an endotracheal tube or tracheostomy, but NOT a facemask) with an anticipated need for > 48 hours of mechanical ventilation Receiving a continuous infusion of any one of: morphine > 2 mg/hour, fentanyl > 20 mcg/hour, or pethidine > 20 mg/hour Either a single GRV > 150 mls (whilst receiving EN via a NG tube) or nasogastric drainage > 500 mls over 12 hours (whether receiving EN or not) Exclusion Criteria: Patients will be ineligible for enrolment if they meet any of the following: Previous or recent surgery which has altered the anatomy of the upper gastrointestinal tract (eg. oesophagectomy, gastrectomy, any gastric anastomosis surgery, gastroplasty, pyloroplasty, pancreaticoduodenectomy [Whipple's procedure]) Known gastric malignancy Known oesophageal varices Current admission for peptic ulceration Current mechanical bowel obstruction Current gastrostomy, jejunostomy, or surgically-placed enteral tube in situ Contraindication to the use of the nose and mouth for enteral tube insertion (eg. recent facial trauma or surgery) Receiving nutritional support prior to ICU admission Severe coagulopathy (defined by platelet count < 20 and/or international normalized ratio [INR] > 4.0)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Davies
Phone
+61 3 92762607
Email
a.davies@alfred.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Siouxzy Morrison
Phone
92071343
Email
s.morrison@alfred.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Davies
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siouxzy Morrison
Phone
92071343
Email
s.morrison@alfred.org.au

12. IPD Sharing Statement

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The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care (ENTERIC) Study

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