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

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ClinicalTrials.gov Identifier: NCT00163813
Recruitment Status : Unknown
Verified August 2005 by Bayside Health.
Recruitment status was:  Not yet recruiting
First Posted : September 14, 2005
Last Update Posted : February 26, 2007
Sponsor:
Information provided by:
Bayside Health

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.

Condition or disease Intervention/treatment Phase
Critical Illness Malabsorption Syndromes Procedure: Early jejunal feeding (using frictional NJ tube) Procedure: Standard feeding (using nasogastric [NG] tube) Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care Study



Primary Outcome Measures :
  1. The amount of EN delivered during the Intensive Care Unit (ICU) stay

Secondary Outcome Measures :
  1. Amount of EN delivered during the first 10 days of the study
  2. Daily cumulative proportion of EN delivered
  3. Ventilator-associated pneumonia rate
  4. Duration of mechanical ventilation
  5. Duration of hospitalisation
  6. Mortality at hospital discharge
  7. Success rate of placement into both the small bowel, generally, and the jejunum, specifically
  8. Complication rates (as compared to the nasogastric tube)


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00163813     History of Changes
Other Study ID Numbers: 232/04
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: February 26, 2007
Last Verified: August 2005

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