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Respiratory Distress Syndrome, AdultPhase 3EDEN-OmegaNCT00609180

Early Versus Delayed Enteral Feeding and Omega-3 Fatty Acid/Antioxidant Supplementation for Treating People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN-Omega Study)

A Phase 3 study testing Minimal (Trophic) Feeding, Full Feeding and Omega-3 Fatty Acids and Antioxidant Supplements in people with Respiratory Distress Syndrome, Adult, run by National Heart, Lung, and Blood Institute (NHLBI) at 41 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions that occur when there is severe inflammation and increased fluids in both lungs, making it difficult for the lungs to function properly. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Respiratory Distress Syndrome, Adult
What is being tested?
Minimal (Trophic) Feeding, Full Feeding and Omega-3 Fatty Acids and Antioxidant Supplements
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
272 participants
Where
41 sitesUnited States
Study dates
Dec 2007to Apr 2009
Phase
Phase 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

  • Must meet the following three criteria at study entry within a 24-hour period: 1) PaO2/FiO2 less than or equal to 300 (if altitude is more than 1000 meters, then PaO2/FiO2 less than or equal to 300 x [barometric pressure/760]), 2) bilateral infiltrates (patchy, diffuse, homogeneous, or asymmetric) consistent with pulmonary edema on frontal chest radiograph, and 3) requirement for positive pressure ventilation via endotracheal tube
  • No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates
  • Intention of primary medical team to enterally feed the patient
  • Undergoes enteral feeding within 48 hours of meeting inclusion criteria

Who cannot join

  • Neuromuscular disease that impairs ability to breath without assistance, such as cervical spinal cord injury at level C5 or higher, amyotrophic lateral sclerosis, Guillain-Barré syndrome, or myasthenia gravis
  • Pregnant or breastfeeding
  • Severe chronic respiratory disease. More information about this criterion can be found in the protocol.
  • Burns on greater than 40% total body surface area
  • Malignancy or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%. More information about this criterion can be found in the protocol.
  • Allogeneic bone marrow transplant within the 5 years before study entry
Show all 28Show fewer
  • Patient, surrogate, 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)
  • Severe chronic liver disease (Child-Pugh score of 11 to 15)
  • Diffuse alveolar hemorrhage from vasculitis
  • Morbid obesity, defined as 1 kg/cm body weight
  • Unwilling or unable to use the ARDS network 6 mL/kg PBW ventilation protocol
  • Moribund patient not expected to survive 24 hours
  • No intent to obtain central venous access for monitoring intravascular pressures
  • More than 72 hours since mechanical ventilation initiated
  • Refractory shock. More information about this criterion can be found in the protocol.
  • Unable to obtain enteral access
  • Presence of partial or complete mechanical bowel obstruction
  • Presence of ischemia or infarction
  • Current total parenteral nutrition (TPN) use or intent to use TPN within 7 days of study entry
  • Severe malnutrition with body mass index less than 18.5 or loss of more than 30% total body weight in the 6 months before study entry
  • Laparotomy expected within 7 days of study entry
  • Unable to raise head of bed 30 to 45 degrees
  • Short-bowel syndrome or absence of gastrointestinal tract
  • Presence of high-output (greater than 500 cc/day) enterocutaneous fistula
  • International normalized ratio greater than 5.0, platelet count less than 30,000/mm3, or history of bleeding disorder
  • Intracranial hemorrhage within the 1 month before study entry
  • Allergy to enteral formula, omega-3 fatty acids, GLA, vitamin E, vitamin C, beta-carotene, taurine, or L-carnitine
  • Requirement for, or physician insistence on, enteral formula supplemented with omega-3 fatty acids (ex: Oxepa®, Impact®) or providing omega-3 fatty acid, GLA, or antioxidant supplementation

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Baltimore VA Medical Center

    Baltimore, Maryland

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland

  • Johns Hopkins Hospital

    Baltimore, Maryland

  • University of Maryland Shock Trauma Center

    Baltimore, Maryland

  • Baton Rouge General Hospital-Blue Bonnet

    Baton Rouge, Louisiana

  • Baton Rouge General Hospital-Midcity

    Baton Rouge, Louisiana

  • Earl K. Long Medical Center

    Baton Rouge, Louisiana

  • Our Lady of the Lake Regional Medical Center

    Baton Rouge, Louisiana

  • University of North Carolina

    Chapel Hill, North Carolina

  • University of Virginia Medical Center

    Charlottesville, Virginia

  • Cleveland Clinic Foundation

    Cleveland, Ohio

  • MetroHealth Medical Center

    Cleveland, Ohio

  • University Hospitals of Cleveland

    Cleveland, Ohio

  • Centura St. Anthony Central Hospital

    Denver, Colorado

  • Denver Health Medical Center

    Denver, Colorado

  • Rose Medical Center

    Denver, Colorado

  • University of Colorado Health Sciences Center

    Denver, Colorado

  • Duke University Medical Center

    Durham, North Carolina

  • Durham Regional Medical Center

    Durham, North Carolina

  • University of San Francisco-Fresno Medical Center

    Fresno, California

  • Moses Cone Health System

    Greensboro, North Carolina

  • Wesley Long Community Hospital

    Greensboro, North Carolina

  • Baylor College of Medicine

    Houston, Texas

  • Intermountain Medical Center

    Murray, Utah

  • Vanderbilt University Medical Center

    Nashville, Tennessee

  • Medical Center of Louisiana

    New Orleans, Louisiana

  • Ochsner Clinic Foundation

    New Orleans, Louisiana

  • Tulane University Health Sciences Center

    New Orleans, Louisiana

  • McKay-Dee Hospital

    Ogden, Utah

  • Utah Valley Regional Medical Center

    Provo, Utah

  • Rochester Methodist Hospital

    Rochester, Minnesota

  • St. Mary's Hospital, Mayo Clinic

    Rochester, Minnesota

  • University of California, Davis Medical Center

    Sacramento, California

  • LDS Hospital

    Salt Lake City, Utah

  • UCSF-Moffitt Hospital

    San Francisco, California

  • UCSF-San Francisco General Hospital

    San Francisco, California

  • Harborview Medical Center

    Seattle, Washington

  • University of Washington

    Seattle, Washington

  • Baystate Medical Center

    Springfield, Massachusetts

  • Washington Hospital Center

    Washington D.C., District of Columbia

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: Prospective, Randomized, Multi-Center Trial of Initial Trophic Enteral Feeding Followed by Advancement to Full-Calorie Enteral Feeding vs. Early Advancement to Full-Calorie Enteral Feeding in Patients With Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) and Prospective, Randomized, Blinded, Placebo-Controlled, Multi-Center Trial of Omega-3 Fatty Acid, Gamma-Linolenic Acid, and Anti-Oxidant Supplementation in the Management of Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS)

Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions that occur when there is severe inflammation and increased fluids in both lungs, making it difficult for the lungs to function properly. Hospital treatment for a person with ALI/ARDS often includes the use of a breathing machine, or ventilator, until the person is able to breathe without assistance. Initiating proper nutrition through a feeding tube early in a person's hospital stay may help to improve recovery, but the optimal timing, composition, and amount of feeding treatments are unknown. This study will evaluate whether early or delayed full-calorie feeding through a feeding tube is more effective in reducing recovery time and increasing survival rates in people with ALI/ARDS. The study will also determine whether supplementing the feedings with omega-3 fatty acids and antioxidants benefits people with ALI/ARDS.

Read the detailed description

ALI/ARDS involves extensive inflammation in the lungs that can lead to rapid respiratory failure. These conditions are most commonly caused by pneumonia, generalized infection, or severe trauma to the lungs, but can also be less commonly caused by smoke or salt water inhalation, drug overdose, or shock.

For some people, ALI/ARDS resolves without treatment, but many severe cases result in hospitalization in the intensive care unit (ICU), where 30% to 40% of cases end in mortality. Current treatments for ALI/ARDS include assisted breathing with a ventilator, supportive care, and management of the underlying causes. Enteral feeding, in which patients receive nutrition through a feeding tube, plays an important role in treatment, too. Some recent studies have shown that, compared to delayed feeding, enteral feeding initiated soon after a patient begins assisted breathing is associated with a shorter hospital stay and a better chance of survival. However, other studies show the opposite, and studies on optimal feeding volume and composition have conflicting results. Studies have also indicated that enhancing enteral feeding with omega-3 fatty acid and antioxidant supplements may help reduce lung inflammation, improving overall recovery rates. This study will evaluate the effects of early versus delayed full-calorie enteral feeding on mortality, ventilator-free days, ICU-free days, and organ failure in people with ALI/ARDS. The study will also determine whether supplementation with omega-3 fatty acid and antioxidants adds any beneficial effect.

Upon admission to the ICU, a dietary evaluation will be done on each participant to determine goal, or full-calorie, feeding rates, which will be based on body weight and daily energy consumption. Participants will also undergo baseline assessments and procedures, which will include vital sign measurements, blood draws, a frontal chest radiograph, ventilator settings, and placement of feeding tube. Participants will be randomly assigned to receive initial enteral feedings that are either minimal (trophic) or full-calorie. They will also be randomly assigned to receive either omega-3 fatty acid and antioxidant supplementation or placebo. All participants will begin enteral feeding within 6 hours of treatment assignment.

Participants assigned to initial minimal enteral feedings will receive feedings at 10 cubic centimeters (cc) per hour, to be continued at this rate for 144 hours, provided that the participant remains on the ventilator. After the 144 hours, the feeding rate will be advanced to full-calorie rates.

Participants assigned to initial full-calorie enteral feedings will receive feedings at 25 cc per hour, and the feeding rate will be increased by 25 cc per hour every 6 hours until goal rate is reached. During enteral feedings, gastric residual volumes (GRVs) will be checked every 6 to 12 hours to assure acceptable levels. Participants will complete enteral feedings upon hospital discharge, Day 28 of treatment, death, or ability to achieve 48 hours of unassisted breathing. Omega-3 fatty acid, antioxidant, and placebo supplements will be administered with a syringe into the participant's feeding tube every 12 hours until Day 21 or discontinuation of the ventilator.

Blood pressure, heart rate, ventilation settings, and various blood factors will be measured during treatment. Phone-based follow-up assessments will occur at Months 6 and 12 after ICU discharge and will include measurements of health-related quality of life; psychological, neurocognitive, and physical activity outcomes; healthcare utilization; and mortality.

Being tested
Minimal (Trophic) Feeding, Full Feeding, Omega-3 Fatty Acids and Antioxidant Supplements, Placebo
Keywords
Acute Lung Injury, Acute Respiratory Distress Syndrome, Feeding, Critical Care, Ventilator, Omega-3 Fatty Acid, Antioxidant
Medical subject headings
Respiratory Distress Syndrome, Acute Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minimal (Trophic) FeedingBehavioural

    Enteral feeds will be started at 10 cc per hour and continued at this rate for 144 hours. After 144 hours of trophic enteral feeds, the feeding rate will be advanced to full-calorie rates, which will continue for the duration of mechanical ventilation up to Day 28.

  • Full FeedingBehavioural

    Upon admission to the ICU, a full-calorie feeding rate will be determined, which will be calculated to deliver 25 to 35 kcal/kg predicted body weight (PBW) each day. Enteral feeds will be initiated at 25 cc per hour. The feeding rate will be increased by 25 cc per hour every 6 hours until goal rate is achieved, which will be administered for the duration of mechanical ventilation up to Day 28.

  • Omega-3 Fatty Acids and Antioxidant SupplementsDietary supplement

    Omega-3 fatty acids, GLA, and antioxidants will be administered through a feeding tube every 12 hours as a 120-cc bolus. Dosing will continue for 21 days or until discontinuation of mechanical ventilation.

  • PlaceboDietary supplement

    Also called TwoCal

    The study placebo will be administered through a feeding tube every 12 hours as a 120 cc bolus. Dosing will continue for 21 days or until discontinuation of mechanical ventilation.

Study groups in NCT00609180
Study groupRoleWhat they receive
1ExperimentalParticipants will receive initial minimal (trophic) enteral feeding and the omega-3 fatty acid and anti-oxidant supplements
Receives: Behavioral: Minimal (Trophic) Feeding; Dietary Supplement: Omega-3 Fatty Acids and Antioxidant Supplements
2ExperimentalParticipants will receive initial full-calorie enteral feeding and the omega-3 fatty acid and anti-oxidant supplements
Receives: Behavioral: Full Feeding; Dietary Supplement: Omega-3 Fatty Acids and Antioxidant Supplements
3ExperimentalParticipants will receive initial minimal (trophic) enteral feeding and the placebo supplement
Receives: Behavioral: Minimal (Trophic) Feeding; Dietary Supplement: Placebo
4Placebo comparatorParticipants will receive initial full-calorie enteral feeding and the placebo supplement
Receives: Behavioral: Full Feeding; Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of ventilator-free days (VFD)

    Measured: Measured at Day 28

  2. Mortality before hospital discharge, with unassisted breathing

    Measured: Measured at Days 60 and 90

Secondary outcomes (8)

  1. Number of intensive care unit-free days

    Measured: Measured at Day 28

  2. Number of organ failure-free days (liver, kidney, heart, central nervous system, and hematologic)

    Measured: Measured at Day 28

  3. Incidence of ventilator-associated pneumonia

    Measured: Measured at Day 28

  4. Number of days from first meeting criteria for weaning readiness to Day 28

    Measured: Measured at Day 28

  5. VFDs and mortality in participants with a partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FIO2) less than or equal to 200 or with shock at the time of study entry

    Measured: Measured at Days 28 and 60, respectively

  6. Change in plasma and mini-bronchoalveolar lavage (BAL) levels of interleukin (IL)-6, IL-8, von Willebrand factor (VWF), surfactant protein D (SPD), and total protein concentrations

    Measured: Measured at Day 3

  7. Health-related quality of life; healthcare utilization; and psychological, neurocognitive, and physical activity outcomes

    Measured: Measured at Months 6 and 12

  8. Duration of survival after hospital discharge using the National Death Index

    Measured: Measured at Months 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionFeb 2009
  4. Study completionApr 2009

Why it stopped: The Omega arm of this study was stopped for futility. The EDEN arm continues to recruit patients as a separate independent study.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00609180
Sponsor's protocol ID
549
Other IDs
N01-HR056179, HSN268200536179C, N01HR056179
Acronym
EDEN-Omega
Status last verified
Feb 2012
First submitted
31 Jan 2008
Last updated
13 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Brown SM, Wilson E, Presson AP, Zhang C, Dinglas VD, Greene T, Hopkins RO, Needham DM; with the National Institutes of Health NHLBI ARDS Network. Predictors of 6-month health utility outcomes in survivors of acute respiratory distress syndrome. Thorax. 2017 Apr;72(4):311-317. doi: 10.1136/thoraxjnl-2016-208560. Epub 2016 Jul 20.

    PubMed 27440140

  • National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.

    PubMed 22307571

  • Rice TW, Wheeler AP, Thompson BT, deBoisblanc BP, Steingrub J, Rock P; NIH NHLBI Acute Respiratory Distress Syndrome Network of Investigators. Enteral omega-3 fatty acid, gamma-linolenic acid, and antioxidant supplementation in acute lung injury. JAMA. 2011 Oct 12;306(14):1574-81. doi: 10.1001/jama.2011.1435. Epub 2011 Oct 5.

    PubMed 21976613

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Minimal (Trophic) Feeding, Full Feeding and Omega-3 Fatty Acids and Antioxidant Supplements in people with Respiratory Distress Syndrome, Adult, run by National Heart, Lung, and Blood Institute (NHLBI) at 41 sites 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 4 inclusion and 28 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: stopped early, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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 was stopped early (reason given: The Omega arm of this study was stopped for futility. The EDEN arm continues to recruit patients as a separate independent study.). Results are not available in the source record.

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?

Number of ventilator-free days (VFD) (time frame: Measured at Day 28). The study lists 2 primary outcomes in all. 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 NCT00609180, which also lists 3 linked publications.

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 13 Apr 2016.

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