Critical IllnessENTERICNCT00163813
The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care (ENTERIC) Study
A study testing Early jejunal feeding (using frictional NJ tube) and Standard feeding (using nasogastric [NG] tube) in people with Critical Illness and Malabsorption Syndromes, run by Bayside Health at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Malabsorption Syndromes
- What is being tested?
- Early jejunal feeding (using frictional NJ tube) and Standard feeding (using nasogastric [NG] tube)
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteAustralia
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Alfred Hospital
Melbourne, Victoria, 3181
Siouxzy Morrison, 92071343, s.morrison@alfred.org.au
About this study
Official title: The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care Study
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
- Being tested
- Early jejunal feeding (using frictional NJ tube), Standard feeding (using nasogastric [NG] tube)
- Keywords
- Mechanically-ventilated, medical-surgical critically ill patients, reduced gastric motility
- Medical subject headings
- Critical Illness, Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early jejunal feeding (using frictional NJ tube)Procedure or surgery
Standard feeding (using nasogastric [NG] tube)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Investigators
- Andrew Davies, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163813
- Sponsor's protocol ID
- 232/04
- Acronym
- ENTERIC
- Status last verified
- Aug 2005
- First submitted
- 12 Sep 2005
- Last updated
- 26 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care Study
- ClinicalTrials.gov ID
- NCT00163813
- Acronym / sponsor ID
- ENTERIC / 232/04
- Conditions
- Critical Illness, Malabsorption Syndromes
- Keywords
- Mechanically-ventilated, medical-surgical critically ill patients, reduced gastric motility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants
- Lead sponsor
- Bayside HealthOther government
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre randomised controlled trial comparing early jejunal feeding (using a frictional nasojejunal [NJ] tube) and standard feeding in critical illness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early jejunal feeding (using frictional NJ tube) | Procedure or surgery | – |
| Standard feeding (using nasogastric [NG] tube) | Procedure or surgery | – |
Primary outcome
The amount of EN delivered during the Intensive Care Unit (ICU) stay
8 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Davies principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early jejunal feeding (using frictional NJ tube) and Standard feeding (using nasogastric [NG] tube) in people with Critical Illness and Malabsorption Syndromes, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Davies (+61 3 92762607, a.davies@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of EN delivered during the Intensive Care Unit (ICU) stay. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2007.