Acute Respiratory FailurePhase 2/3NCT00252616
Timing of Target Enteral Feeding in the Mechanically Ventilated Patient
A Phase 2/3 study testing trophic enteral feeds in people with Acute Respiratory Failure, run by Vanderbilt University at 1 site in United States.
Trial summary
This study tests the hypothesis that initial trophic enteral feedings will increase the time alive and free of mechanical ventilation as compared to initial goal enteral feedings in patients who are mechanically ventilated. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- trophic enteral feeds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Oct 2009
- Phase
- Phase 2/3
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- More than 48 hours elapsed since both inclusion criteria met.
- Patient, legal representative, or physician refuses consent or is unavailable to provide consent.
- Patient, legal representative, or physician not committed to full support (Exception: A patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest).
- Presence of malignant or irreversible condition and estimated 28 day mortality greater than 50%.
- Severe or refractory shock.
- Moribund patients not expected to survive 24 hours from start of enteral feeding (as determined by primary medical team).
Show all 18Show fewer
- Child-Pugh score greater than 10.
- Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction.
- Current TPN use or intent to use TPN within 7 days.
- Severe malnutrition with BMI less than 18.5 and/or loss of more than 30% total body weight in the previous 6 months.
- Neuromuscular disease impairing the ability to ventilate spontaneously.
- Laparotomy expected within 7 days.
- Unable to raise head of bed 45°.
- greater than 30% total body surface area burns.
- Absence of GI tract/short bowel syndrome - defined as entire length of small bowel totaling 4 feet or less.
- Presence of high-output (> 500 cc/day) enterocutaneous fistula.
- Age less than 13 years
- Allergy to enteral formula
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Phase III Study of Early vs. Delayed Goal Enteral Nutrition in Mechanically Ventilated Patients
This study tests the hypothesis that initial trophic enteral feedings will increase the time alive and free of mechanical ventilation as compared to initial goal enteral feedings in patients who are mechanically ventilated.
Read the detailed description
Mechanically ventilated patients, within 48 hours of initiating mechanical ventilation, are randomized in a 1:1 fashion to receive trophic enteral feedings for 96 hours followed by advancement to goal feeding rates or initial advancement to goal feeding rates. Primary endpoints are ventilator free days, ICU-free days, gastrointestinal intolerances, development of nosocomial infections, and mortality.
- Conditions
- Acute Respiratory Failure
- Being tested
- trophic enteral feeds
- Keywords
- Mechanical ventilation, acute respiratory failure, early nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trophic enteral feedsBehavioural
10cc/hr
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | trophic feeds Receives: Behavioral: trophic enteral feeds |
| 2 | Active comparator | Full-calorie feeds Receives: Behavioral: trophic enteral feeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days
Measured: day 28
Secondary outcomes (6)
ICU-free days
Measured: day 28
Mortality
Measured: 28 days
Incidence of Gastrointestinal intolerances
Measured: day 14
Organ failure-free days
Measured: day 28
Changes in inflammation as measured by serum cytokine levels
Measured: baseline vs. days 6 and 12
Changes in levels of nutrition as measured by serum albumin, total protein, and pre-albumin
Measured: baseline vs. days 6 or 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startSep 2003
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Todd Rice, Vanderbilt University
- Investigators
- Todd W Rice, MD, MSc, Principal investigator, Vanderbilt University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252616
- Sponsor's protocol ID
- 020744
- Status last verified
- Dec 2013
- First submitted
- 9 Nov 2005
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rice TW, Mogan S, Hays MA, Bernard GR, Jensen GL, Wheeler AP. Randomized trial of initial trophic versus full-energy enteral nutrition in mechanically ventilated patients with acute respiratory failure. Crit Care Med. 2011 May;39(5):967-74. doi: 10.1097/CCM.0b013e31820a905a.
PubMed 21242788
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Early vs. Delayed Goal Enteral Nutrition in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT00252616
- Acronym / sponsor ID
- 020744
- Conditions
- Acute Respiratory Failure
- Keywords
- Mechanical ventilation, acute respiratory failure, early nutrition
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2003
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 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.
This study tests the hypothesis that initial trophic enteral feedings will increase the time alive and free of mechanical ventilation as compared to initial goal enteral feedings in patients who are mechanically ventilated.
Detailed description
Mechanically ventilated patients, within 48 hours of initiating mechanical ventilation, are randomized in a 1:1 fashion to receive trophic enteral feedings for 96 hours followed by advancement to goal feeding rates or initial advancement to goal feeding rates. Primary endpoints are ventilator free days, ICU-free days, gastrointestinal intolerances, development of nosocomial infections, and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: trophic enteral feedstrophic feeds |
| 2 | Active comparator | Behavioral: trophic enteral feedsFull-calorie feeds |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- More than 48 hours elapsed since both inclusion criteria met.
- Patient, legal representative, or physician refuses consent or is unavailable to provide consent.
- Patient, legal representative, or physician not committed to full support (Exception: A patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest).
- Presence of malignant or irreversible condition and estimated 28 day mortality greater than 50%.
- Severe or refractory shock.
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 |
|---|---|---|
| trophic enteral feeds10cc/hr | Behavioural | 1, 2 |
Primary outcome
Ventilator-free days
Time frame: day 28
6 secondary outcomes
ICU-free days
Time frame: day 28
Mortality
Time frame: 28 days
Incidence of Gastrointestinal intolerances
Time frame: day 14
Organ failure-free days
Time frame: day 28
Changes in inflammation as measured by serum cytokine levels
Time frame: baseline vs. days 6 and 12
Changes in levels of nutrition as measured by serum albumin, total protein, and pre-albumin
Time frame: baseline vs. days 6 or 12
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 17 Dec 2013.
- Derived from this study: PubMed 21242788Rice TW, Mogan S, Hays MA, Bernard GR, Jensen GL, Wheeler AP. Randomized trial of initial trophic versus full-energy enteral nutrition in mechanically ventilated patients with acute respiratory failure. Crit Care Med. 2011 May;39(5):967-74. doi: 10.1097/CCM.0b013e31820a905a.
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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.
Todd W Rice, MD, MSc principal investigator
Vanderbilt University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing trophic enteral feeds in people with Acute Respiratory Failure, run by Vanderbilt University at 1 site in United States.
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 0 inclusion and 18 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 17 Dec 2013. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ventilator-free days (time frame: day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00252616, which also lists 1 linked publication.
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 17 Dec 2013.