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

NCT00163813 | Unknown

• 1 other identifier: 232/04
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Malabsorption Syndromes

Keywords

Mechanically-ventilated; medical-surgical critically ill patients; reduced gastric motility

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

• 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

Interventions

Early jejunal feeding (using frictional NJ tube) PROCEDURE

Standard feeding (using nasogastric [NG] tube) PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

MeSH Terms

Conditions

Critical Illness; Malabsorption Syndromes

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andrew Davies

  The Alfred

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Davies

CONTACT

+61 3 92762607; a.davies@alfred.org.au

Siouxzy Morrison

CONTACT

92071343; s.morrison@alfred.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Last Updated: February 26, 2007

Record last verified: 2005-08

Locations

AU (1)