NCT01096771 is a Phase 2 clinical trial of ClinOleic 20% in Acute Respiratory Distress Syndrome, sponsored by Methodist Research Institute, Indianapolis.

Who is sponsoring NCT01096771?

NCT01096771 is sponsored by Methodist Research Institute, Indianapolis.

What drugs are being tested in NCT01096771?

Interventions in NCT01096771: ClinOleic 20%, Intralipid 20%.

What condition does NCT01096771 study?

NCT01096771 studies Acute Respiratory Distress Syndrome.

Is NCT01096771 still recruiting?

NCT01096771 is currently terminated. Last updated 25 April 2014.

Are results published for NCT01096771?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-04-25 · How we verify

NCT01096771

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effect of Intravenous Lipid Emulsions on Lung Function in ARDS: A Pilot Study

Terminated Phase 2 Results posted Last updated 25 April 2014

What this trial tests

Phase 2 trial testing ClinOleic 20% in Acute Respiratory Distress Syndrome in 14 participants. Terminated before completion.

Timeline

1 June 2010

Primary endpoint
1 November 2012

1 November 2012

Quick facts

Lead sponsor	Methodist Research Institute, Indianapolis
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	14
Start date	1 June 2010
Primary completion	1 November 2012
Estimated completion	1 November 2012
Sites	1 location across United States

Drugs / interventions tested

ClinOleic 20% — full drug profile →
Intralipid 20% — full drug profile →

Conditions studied

Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →

Sponsor

Methodist Research Institute, Indianapolis

Who can join

Adults 18 to 90, any sex, with Acute Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations
Time frame: 96 hours

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

What every intensivist should know about acute respiratory distress syndrome and diffuse alveolar damage.
Rios F, Iscar T, Cardinal-Fernández P. · · 2017 · cited 17× · PMID 28977098 · DOI 10.5935/0103-507x.20170044
Role of Olive Bioactive Compounds in Respiratory Diseases.
Vijakumaran U, Goh NY, Razali RA, Abdullah NAH, et al · · 2023 · cited 7× · PMID 37371870 · DOI 10.3390/antiox12061140

Verify or expand the search:

Other recruiting trials for Acute Respiratory Distress Syndrome

Currently open trials in the same condition.

NCT07284888 — Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry- · recruiting
NCT07289711 — Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter C · recruiting
NCT07326215 — A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+ · NA · recruiting
NCT06919484 — The Physiological Effect of RCexp on Ventilation/Perfusion Distribution · recruiting
NCT07126964 — Extended Prone Positioning for Intubated ARDS · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01096771 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Methodist Research Institute, Indianapolis
Last refreshed: 25 April 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01096771.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing