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

Not Applicable

• Conditions: Critical Illness; Malabsorption Syndromes

• Registration Number: NCT00163813
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Last Update Submitted: 2007-02-23
• Last Update Posted: 2007-02-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The amount of EN delivered during the Intensive Care Unit (ICU) stay

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia