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

Critical Illness Clinical Trial

— ENTERIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00163813
• Other study ID #: 232/04
• Status: Not yet recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: February 23, 2007

Study information

• Verified date: August 2005
• Source: Bayside Health
• Contact: Andrew Davies
• Phone: +61 3 92762607
• Email: a.davies[@]alfred.org.au
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Malabsorption Syndromes

Intervention

Procedure:
• Early jejunal feeding (using frictional NJ tube)

• Standard feeding (using nasogastric [NG] tube)

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of EN delivered during the Intensive Care Unit (ICU) stay
Secondary	Amount of EN delivered during the first 10 days of the study
Secondary	Daily cumulative proportion of EN delivered
Secondary	Ventilator-associated pneumonia rate
Secondary	Duration of mechanical ventilation
Secondary	Duration of hospitalisation
Secondary	Mortality at hospital discharge
Secondary	Success rate of placement into both the small bowel, generally, and the jejunum, specifically
Secondary	Complication rates (as compared to the nasogastric tube)