Critically IllNCT00256048
Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
A study testing Nasojejunal feeding in people with Critically Ill, run by Melbourne Health at 1 site in Australia.
Trial summary
The purpose of this study is to determine if naso-jejunal feeding (feeding beyond the stomach) improves the efficacy of enteral feeding (feeding into the gut) in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Nasojejunal feeding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- May 2003to Jul 2005
- 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
- Adult patients (18years or over) admitted to the ICU with an expected stay of more than 48 hours.
- Patients commenced on enteral feeding via a nasogastric tube who fail to tolerate gastric feeding due to excessive gastric aspirate volumes.
- Patients who consent or if the patient is incompetent, the next of kin, who consent, to inclusion in the study.
- -
Who cannot join
- patients less than 18 years of age.
- Patients with known allergy to promotility agents, metoclopramide or erythromycin.
- Patients with a contra indication to nasojejunal feeding. -
Trial locations and contacts
1 site in 1 country.
Australia1 site
Intensive Care Unit, Royal Melbourne Hospital, Grattan Street
Parkville, Victoria, 3050
About this study
The purpose of this study is to determine if naso-jejunal feeding (feeding beyond the stomach) improves the efficacy of enteral feeding (feeding into the gut) in critically ill patients.
The study hypothesis is that in patients who fail to establish enteral feeding via the nasogastric route, introduction of nasojejunal feeding will lead to more effective enteral feeding than the current regime involving staged introduction of promotility agents.
Read the detailed description
The study examines the area of enteral feeding in critically ill patients. Current standard enteral feeding practice is via a nasogastric with the addition of promotility agents for patients who fail to absorb their enteral nutrition.
This study compares the efficacy of nasojejunal feeding feeding with nasogastric enteral feeding with the addition of promotility agents.
The duration of feeding will be determined by the patients nutritional requirements and their general condition. However the data will be collected for duration of enteral feeding, 28 days or ICU discharge whichever occurs first.
- Conditions
- Critically Ill
- Being tested
- Nasojejunal feeding
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasojejunal feedingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Patients will receive enteral nutrition via a nasogastric tube as per standard feeding regime |
| Nasojejunal Arm | Active comparator | Patient will receive feeding via a nasojejunal feeding tube Receives: Procedure: Nasojejunal feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of feeding
Measured: participants will be followed until death, discharge from ICU, commencement of oral or parental nutrition or 28 days post ICU admission
Secondary outcomes (2)
1. To determine the incidence of complications with enteral feeding via nasogastric and nasojejunal routes.
Measured: participants will be followed until death, discharge from ICU, commencement of parental or oral nutrition or 28 days post ICU admission.
2. To assess the efficacy of current strategies for optimising enteral feeding efficacy.
Measured: participants will be followed until death, discharge from ICU commencement of oral or parental nutrition,or 28 days post ICU admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startMay 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Investigators
- Megan Robertson, Principal investigator, Intensive Care Unit, Royal Melbourne Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256048
- Sponsor's protocol ID
- 2002.228
- Status last verified
- Apr 2015
- First submitted
- 17 Nov 2005
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT00256048
- Acronym / sponsor ID
- 2002.228
- Conditions
- Critically Ill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Jul 2005 (actual)
- First posted
- 21 Nov 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.
The purpose of this study is to determine if naso-jejunal feeding (feeding beyond the stomach) improves the efficacy of enteral feeding (feeding into the gut) in critically ill patients.
The study hypothesis is that in patients who fail to establish enteral feeding via the nasogastric route, introduction of nasojejunal feeding will lead to more effective enteral feeding than the current regime involving staged introduction of promotility agents.
Detailed description
The study examines the area of enteral feeding in critically ill patients. Current standard enteral feeding practice is via a nasogastric with the addition of promotility agents for patients who fail to absorb their enteral nutrition.
This study compares the efficacy of nasojejunal feeding feeding with nasogastric enteral feeding with the addition of promotility agents.
The duration of feeding will be determined by the patients nutritional requirements and their general condition. However the data will be collected for duration of enteral feeding, 28 days or ICU discharge whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Patients will receive enteral nutrition via a nasogastric tube as per standard feeding regime |
| Nasojejunal Arm | Active comparator | Procedure: Nasojejunal feedingPatient will receive feeding via a nasojejunal feeding tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (18years or over) admitted to the ICU with an expected stay of more than 48 hours.
- Patients commenced on enteral feeding via a nasogastric tube who fail to tolerate gastric feeding due to excessive gastric aspirate volumes.
- Patients who consent or if the patient is incompetent, the next of kin, who consent, to inclusion in the study.
- -
Key exclusion criteria (3 listed)
- patients less than 18 years of age.
- Patients with known allergy to promotility agents, metoclopramide or erythromycin.
- Patients with a contra indication to nasojejunal feeding. -
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 |
|---|---|---|
| Nasojejunal feeding | Procedure or surgery | Nasojejunal Arm |
Primary outcome
Efficacy of feeding
Time frame: participants will be followed until death, discharge from ICU, commencement of oral or parental nutrition or 28 days post ICU admission
2 secondary outcomes
1. To determine the incidence of complications with enteral feeding via nasogastric and nasojejunal routes.
Time frame: participants will be followed until death, discharge from ICU, commencement of parental or oral nutrition or 28 days post ICU admission.
2. To assess the efficacy of current strategies for optimising enteral feeding efficacy.
Time frame: participants will be followed until death, discharge from ICU commencement of oral or parental nutrition,or 28 days post ICU admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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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.
Megan Robertson principal investigator
Intensive Care Unit, Royal Melbourne Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasojejunal feeding in people with Critically Ill, run by Melbourne 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 12 Apr 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of feeding (time frame: participants will be followed until death, discharge from ICU, commencement of oral or parental nutrition or 28 days post ICU admission). 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 12 Apr 2017.