Acute Respiratory Distress SyndromePhase 2NCT01096771
The Effect of Intravenous Lipids on Lung Function in Acute Respiratory Distress Syndrome (ARDS)
A Phase 2 study testing ClinOleic 20% and Intralipid 20% in people with Acute Respiratory Distress Syndrome, run by Methodist Research Institute, Indianapolis at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of nutritional supplementation with omega-9 "olive-oil" and omega-6 "soybean oil" based lipid emulsions in the Acute Respiratory Distress Syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- ClinOleic 20% and Intralipid 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with predisposing condition causing ARDS
- are mechanically ventilated through an endotracheal tube
- have enteral feeding access
- have central venous access
- have a PaO2:FiO2 ratio of less than 200
- have bilateral pulmonary infiltrates on chest x-ray
Who cannot join
- sedation requiring the use of diprivan (after enrollment)
- a clinical diagnosis of left ventricular failure
- lung cancer
- hematologic malignancy
- severe dyslipidemia
- condition precluding bronchoscopy including inability to maintain oxygen saturations greater than 90% per pulse oximetry despite conventional mechanical ventilation
Show all 14Show fewer
- severe immunosuppression
- use of NSAIDS within previous 24 hours
- HIV positive
- pregnancy
- hypersensitivity to egg or soybean oil
- active myocardial infarction
- acute pancreatitis if complicated by hypertriglyceridemia
- severe sepsis with 2 or more organ failures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intravenous Lipid Emulsions on Lung Function in ARDS: A Pilot Study
The purpose of this study is to evaluate the effects of nutritional supplementation with omega-9 "olive-oil" and omega-6 "soybean oil" based lipid emulsions in the Acute Respiratory Distress Syndrome (ARDS). The investigators hypothesize that these specific lipids in combination will immunomodulate the inflammatory reaction that occurs in the lungs of ARDS subjects. This concept is known as "Pharmaconutrition." These lipids will be given intravenously so as to assure administration and only as a supplement to enteral nutrition which all subjects will also receive. The omega-9 will be compared to the omega-6 formulation which is the only FDA approved formulation of use in the United States since its development in 1961 by Fresenius-Kabi, Bad Homburg, Germany. The investigators plan to perform a bronchoscopy with lavage within 24 hours of enrollment, begin the lipid administration and continue it for 96 hours after which time the investigators will repeat bronchoscopy with lavage to assess changes. The lipid administration will cease following the second bronchoscopy. The fluid obtained from lavage combined with serum samples obtained at the time of bronchoscopy will be analyzed for inflammatory mediators and cell counts. Clinical data tracing will include but not be limited to: ventilator days, nutritional status, ICU time, oxygenation and lung compliance, and 30-day mortality.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- ClinOleic 20%, Intralipid 20%
- Keywords
- ARDS, Parenteral, Pharmaconutrition
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClinOleic 20%Drug
96 hour continuous infusion.
Intralipid 20%Drug
96 hour continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| ClinOleic 20% | Experimental | 96 hour continuous infusion. Receives: Drug: ClinOleic 20% |
| Intralipid 20% | Active comparator | 96 hour continuous infusion. Receives: Drug: Intralipid 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations
Measured: 96 hours
Secondary outcomes (9)
Ventilator Days
Measured: 30 days
PaO2:FiO2 Ratio
PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.
Measured: 4 days
30 Day Mortality
Measured: 30 days
New Infection
We will use standard clinical criteria including but not limited to: fever, pyuria, new inflitrate on chest x-ray, positive blood cultures, abscess detected on imaging, leukocytosis, and positive skin or soft-tissue cultures to identify presence of new bacterial infections occurring after enrollment.
Measured: 30 days
Organ Failures
Measured: 30 days
Biomarkers (C-reactive Protein)
Measured: 96 hours
Hospital Length of Stay
Measured: 30 days
Allergic Reactions
Measured: 96 hours
Hypertriglyceridemia
Defined as triglyceride level >400
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Unable to secure product from international source, low recruitment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Research Institute, Indianapolis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W. Graham Carlos, Methodist Research Institute, Indianapolis
- Investigators
- Chris Naum, MD, Principal investigator, Indiana Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096771
- Sponsor's protocol ID
- Lipids for ARDS
- Status last verified
- Apr 2014
- First submitted
- 24 Mar 2010
- Last updated
- 26 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Lipid Emulsions on Lung Function in ARDS: A Pilot Study
- ClinicalTrials.gov ID
- NCT01096771
- Acronym / sponsor ID
- Lipids for ARDS
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Parenteral, Pharmaconutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to secure product from international source, low recruitment rate.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Methodist Research Institute, IndianapolisUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Posted 26 May 2014
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 evaluate the effects of nutritional supplementation with omega-9 "olive-oil" and omega-6 "soybean oil" based lipid emulsions in the Acute Respiratory Distress Syndrome (ARDS). The investigators hypothesize that these specific lipids in combination will immunomodulate the inflammatory reaction that occurs in the lungs of ARDS subjects. This concept is known as "Pharmaconutrition." These lipids will be given intravenously so as to assure administration and only as a supplement to enteral nutrition which all subjects will also receive. The omega-9 will be compared to the omega-6 formulation which is the only FDA approved formulation of use in the United States since its development in 1961 by Fresenius-Kabi, Bad Homburg, Germany. The investigators plan to perform a bronchoscopy with lavage within 24 hours of enrollment, begin the lipid administration and continue it for 96 hours after which time the investigators will repeat bronchoscopy with lavage to assess changes. The lipid administration will cease following the second bronchoscopy. The fluid obtained from lavage combined with serum samples obtained at the time of bronchoscopy will be analyzed for inflammatory mediators and cell counts. Clinical data tracing will include but not be limited to: ventilator days, nutritional status, ICU time, oxygenation and lung compliance, and 30-day mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ClinOleic 20% | Experimental | Drug: ClinOleic 20%96 hour continuous infusion. |
| Intralipid 20% | Active comparator | Drug: Intralipid 20%96 hour continuous infusion. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosed with predisposing condition causing ARDS
- are mechanically ventilated through an endotracheal tube
- have enteral feeding access
- have central venous access
- have a PaO2:FiO2 ratio of less than 200
Key exclusion criteria (14 listed)
- sedation requiring the use of diprivan (after enrollment)
- a clinical diagnosis of left ventricular failure
- lung cancer
- hematologic malignancy
- severe dyslipidemia
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 |
|---|---|---|
| ClinOleic 20%96 hour continuous infusion. | Drug | ClinOleic 20% |
| Intralipid 20%96 hour continuous infusion. | Drug | Intralipid 20% |
Primary outcome
Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations
Time frame: 96 hours
9 secondary outcomes
Ventilator Days
Time frame: 30 days
PaO2:FiO2 Ratio
Time frame: 4 days
30 Day Mortality
Time frame: 30 days
New Infection
Time frame: 30 days
Organ Failures
Time frame: 30 days
Biomarkers (C-reactive Protein)
Time frame: 96 hours
Hospital Length of Stay
Time frame: 30 days
Allergic Reactions
Time frame: 96 hours
Hypertriglyceridemia
Time frame: 96 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chris Naum, MD principal investigator
Indiana Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ClinOleic 20% and Intralipid 20% in people with Acute Respiratory Distress Syndrome, run by Methodist Research Institute, Indianapolis 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 6 inclusion and 14 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 26 May 2014. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations (time frame: 96 hours). 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 May 2014.