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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Bayside Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163813
First received: September 12, 2005
Last updated: February 23, 2007
Last verified: August 2005
History of Changes
  Purpose

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


Condition Intervention
Critical Illness
Malabsorption Syndromes
 Procedure: Early jejunal feeding (using frictional NJ tube)
Procedure: Standard feeding (using nasogastric [NG] tube)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayside Health:

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)

Estimated Enrollment: 180
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163813

Contacts
Contact: Andrew Davies +61 3 92762607 a.davies@alfred.org.au
Contact: Siouxzy Morrison 92071343 s.morrison@alfred.org.au

Locations
Australia, Victoria
Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3181
Contact: Siouxzy Morrison     92071343     s.morrison@alfred.org.au    
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Andrew Davies The Alfred Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163813     History of Changes
Other Study ID Numbers: 232/04
Study First Received: September 12, 2005
Last Updated: February 23, 2007
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:
Mechanically-ventilated
medical-surgical critically ill patients
reduced gastric motility

Additional relevant MeSH terms:
Critical Illness
Malabsorption Syndromes
Disease Attributes
Pathologic Processes
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013