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

• Sponsor: Bayside Health (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00163813
• Collaborator: (none)
• Enrollment: 180
• Location: 1

Study Details

Study Description

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)	N/A

Study Design

• Study Type: Interventional
• 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

Outcome Measures

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) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Alfred Hospital	Melbourne	Victoria	Australia	3181

Sponsors and Collaborators

• Bayside Health

Investigators

• Principal Investigator: Andrew Davies, The Alfred

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00163813
• Other Study ID Numbers: 232/04
• First Posted: Sep 14, 2005
• Last Update Posted: Feb 26, 2007
• Last Verified: Aug 1, 2005

• Keywords provided by , ,: Mechanically-ventilated; medical-surgical critically ill patients; reduced gastric motility
• Additional relevant MeSH terms: Malabsorption Syndromes; Critical Illness

Study Results

No Results Posted as of Feb 26, 2007