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

This study is not yet open for participant recruitment.
Verified by Bayside Health, August 2005

Sponsored by: Bayside Health
Information provided by: Bayside Health
ClinicalTrials.gov Identifier: NCT00163813
  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)

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care Study

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


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

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

Study placed in the following topic categories:
Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Critical Illness
Malabsorption Syndromes
Metabolic disorder
Intestinal Diseases

Additional relevant MeSH terms:
Disease Attributes
Disease
Pathologic Processes
Syndrome

ClinicalTrials.gov processed this record on September 19, 2008




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