Respiratory Distress Syndrome,AdultPhase 3NCT01464853
Effect of Enteral Nutrition Support for Critically Ill Patients
A Phase 3 study testing Enteral nutrition with fatty acids and Standard Enteral Nutrition in people with Respiratory Distress Syndrome,Adult and Acute Lung Injury, run by Abbott Nutrition at 9 sites in Russia.
Trial summary
To determine whether specialized enteral nutrition support can improve oxygenation status in critically ill patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) comparing to a standard enteral nutritional formula. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Respiratory Distress Syndrome,Adult, Acute Lung Injury
- What is being tested?
- Enteral nutrition with fatty acids and Standard Enteral Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 9 sitesRussia
- Study dates
- Apr 2010to May 2011
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female.
- ALI or ARDS
- PaO2/FiO2 > 100 and ≤ 300 torr.
- Evidence of bilateral pulmonary infiltrates/opacity on chest radiograph.
- Enteral access
- Systemic inflammatory response syndrome (SIRS) - two or more of the following must be present:
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- Body temperature less than 36°C or greater than 38°C
- Heart rate > 90 beats per minute
- Tachypnea with > 20 breaths per minute; or an arterial partial pressure of carbon dioxide < 4.3 kPa (32 mmHg)
- White blood cell count < 4000 cells/mm³ or > 12,000 cells/mm³; or the presence of > 10% immature neutrophils.
Who cannot join
- Dialysis for renal failure
- Unable to initiate Enteral feeding within 48 hours since all inclusion criteria met.
- Anticipated life expectancy less than 24 hours.
- Patient with severe chronic liver disease
- Neuromuscular disease that impairs ability to ventilate without assistance
- Head trauma and/or drowning with a Glasgow coma score of 5
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- Receiving intravenous lipid emulsions from parenteral nutrition within 12 hours of baseline.
- Receiving propofol
- Airway reconstructive surgery.
- Malignancy or irreversible disease for which 6-month mortality is greater than 50%.
- Burns greater than 25% total body surface area.
- Unwillingness or inability to utilize the ARDS network ventilation protocol.
- HIV positive.
- Chronic mechanical ventilation.
- Severe, acute pancreatitis.
- Refractory shock
- Congestive heart failure with pulmonary edema as the primary cause of hypoxemia.
- Acute myocardial infarction or cardiac surgery within 7 days.
- Solid organ transplant.
- INR > 5.0 or platelet count < 30,000/mm3 or history of bleeding disorder.
- Intracranial hemorrhage within the past 30 days.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites
1st City Clinical Emergency Hospital n.a. E.E. Volosevich
Arkhangelsk, 163001
City Clinical Hospital #2
Krasnodar, 350012
Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo
Krasnoyarsk, 660022
Central Clinical Hospital #1
Moscow, 125367
State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087
Clinical Medical Unit #1
Perm, 614010
St. Petersburg Scientific Research Institute of Emergency Care n.a. I.I.Dzhanelidze
Saint Petersburg, 192442
Republican Clinical Hospital n.a. G.G. Kuvatova
Ufa, 45005
Central City Hospital #7
Yekaterinburg, 620109
About this study
To determine whether specialized enteral nutrition support can improve oxygenation status in critically ill patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) comparing to a standard enteral nutritional formula.
- Being tested
- Enteral nutrition with fatty acids, Standard Enteral Nutrition
- 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.
Enteral nutrition with fatty acidsOther
Enteral Feeding to provide 25 kcal/Kg/day
Standard Enteral NutritionOther
Enteral Feeding to provide 25 kcal/Kg/day
| Study group | Role | What they receive |
|---|---|---|
| Specialized Enteral Nutrition | Experimental | Enteral Feeding to provide 25 kcal/Kg/day Receives: Other: Enteral nutrition with fatty acids |
| Standard Enteral Nutrition | Active comparator | Enteral Feeding to provide 25 kcal/Kg/day Receives: Other: Standard Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation status improvement
Measured: 28 days
Secondary outcomes (8)
Length of ventilation
Measured: 28 days
Length of ICU stay
Measured: 28 days
Incidence of organ failures
Measured: 28 days
Incidence of ventilator-associated pneumonia
Measured: 28 days
Mortality
Measured: 28 days
Glycemic control
Measured: 28 days
Inflammation
Measured: 28 days
Vitamin D status
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionMay 2011
Why it stopped: Interim analysis indicated significant additional subjects needed to demonsate statistical difference in primary outcome.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome,AdultStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Menghua Luo, MD, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464853
- Sponsor's protocol ID
- BK54
- Status last verified
- Mar 2011
- First submitted
- 1 Nov 2011
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enteral Nutrition Support for Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01464853
- Acronym / sponsor ID
- BK54
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis indicated significant additional subjects needed to demonsate statistical difference in primary outcome.
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 Nov 2011 (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.
To determine whether specialized enteral nutrition support can improve oxygenation status in critically ill patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) comparing to a standard enteral nutritional formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialized Enteral Nutrition | Experimental | Other: Enteral nutrition with fatty acidsEnteral Feeding to provide 25 kcal/Kg/day |
| Standard Enteral Nutrition | Active comparator | Other: Standard Enteral NutritionEnteral Feeding to provide 25 kcal/Kg/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or non-pregnant female.
- ALI or ARDS
- PaO2/FiO2 > 100 and ≤ 300 torr.
- Evidence of bilateral pulmonary infiltrates/opacity on chest radiograph.
- Enteral access
Key exclusion criteria (21 listed)
- Dialysis for renal failure
- Unable to initiate Enteral feeding within 48 hours since all inclusion criteria met.
- Anticipated life expectancy less than 24 hours.
- Patient with severe chronic liver disease
- Neuromuscular disease that impairs ability to ventilate without assistance
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 |
|---|---|---|
| Enteral nutrition with fatty acidsEnteral Feeding to provide 25 kcal/Kg/day | Other | Specialized Enteral Nutrition |
| Standard Enteral NutritionEnteral Feeding to provide 25 kcal/Kg/day | Other | Standard Enteral Nutrition |
Primary outcome
Oxygenation status improvement
Time frame: 28 days
8 secondary outcomes
Length of ventilation
Time frame: 28 days
Length of ICU stay
Time frame: 28 days
Incidence of organ failures
Time frame: 28 days
Incidence of ventilator-associated pneumonia
Time frame: 28 days
Mortality
Time frame: 28 days
Glycemic control
Time frame: 28 days
Inflammation
Time frame: 28 days
Vitamin D status
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Interim analysis indicated significant additional subjects needed to demonsate statistical difference in primary outcome.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
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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.
Menghua Luo, MD, PhD study chair
Abbott Nutrition
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enteral nutrition with fatty acids and Standard Enteral Nutrition in people with Respiratory Distress Syndrome,Adult and Acute Lung Injury, run by Abbott Nutrition at 9 sites in Russia.
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 10 inclusion and 21 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 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia. 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 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: Interim analysis indicated significant additional subjects needed to demonsate statistical difference in primary outcome.). 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?
Oxygenation status improvement (time frame: 28 days). 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 4 Nov 2011.