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

February 23, 2007 updated by: Bayside Health

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Duration of mechanical ventilation
Duration of hospitalisation
Amount of EN delivered during the first 10 days of the study
Daily cumulative proportion of EN delivered
Ventilator-associated pneumonia rate
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Investigators

  • Principal Investigator: Andrew Davies, The Alfred

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 14, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 26, 2007

Last Update Submitted That Met QC Criteria

February 23, 2007

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 232/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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