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Unable to secure product from international source, low recruitment rate.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ClinOleic 20% | Experimental | 96 hour continuous infusion. |
|
| Intralipid 20% | Active Comparator | 96 hour continuous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClinOleic 20% | Drug | 96 hour continuous infusion. |
| |
| Intralipid 20% |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations | 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator Days | 30 days | |
| PaO2:FiO2 Ratio | PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration. | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Naum, MD | Indiana Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental ClinOleic 20% | Patients received dietary supplement with ClinOleic 20%. |
| FG001 | Control: Intralipid 20% | Patients received dietary supplement with Intralipid 20%. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental ClinOleic 20% | Patients received dietary supplement with ClinOleic 20%. |
| BG001 | Control: Intralipid 20% | Patients received dietary supplement with Intralipid 20%. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations | Each arm has one less subject than specified in the participate flow module. One is secondary to the fact that the subject refused the 2nd bronchoscopy and the other is because the primary physician felt the subject was too sick to undergo the 2nd bronchscopy. | Posted | Mean | Standard Deviation | pg/mL | 96 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental ClinOleic 20% | Patients received dietary supplement with ClinOleic 20%. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Patient died after study infusion drug completed. Mortality rate for ARDS is >25%. While this is a SAE it is not unexpected and could not be directly connected to study experimental or control drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | An adverse event was considered a rise in the serum creatinine level while on the study experimental or control drug. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Carlos | Indiana University School of Medicine | 3178807819 | wcarlos@iu.edu |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| Drug |
96 hour continuous infusion. |
|
| 30 Day Mortality | 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. | 30 days |
| Organ Failures | 30 days |
| Biomarkers (C-reactive Protein) | 96 hours |
| Hospital Length of Stay | 30 days |
| Allergic Reactions | 96 hours |
| Hypertriglyceridemia | Defined as triglyceride level >400 | 96 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Ventilator Days | Posted | Mean | Standard Deviation | days | 30 days |
|
|
|
| Secondary | PaO2:FiO2 Ratio | PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration. | Posted | Mean | Standard Deviation | mmHg | 4 days |
|
|
|
| Secondary | 30 Day Mortality | Posted | Number | participants | 30 days |
|
|
|
| Secondary | 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. | Posted | Number | participants | 30 days |
|
|
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| Secondary | Organ Failures | Posted | Number | participants | 30 days |
|
|
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| Secondary | Biomarkers (C-reactive Protein) | Posted | Mean | Standard Deviation | mg/L | 96 hours |
|
|
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| Secondary | Hospital Length of Stay | Posted | Mean | Standard Deviation | days | 30 days |
|
|
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| Secondary | Allergic Reactions | Posted | Number | participants | 96 hours |
|
|
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| Secondary | Hypertriglyceridemia | Defined as triglyceride level >400 | Posted | Number | participants | 96 hours |
|
|
|
| 1 |
| 7 |
| 1 |
| 7 |
| EG001 | Control: Intralipid 20% | Patients received dietary supplement with Intralipid 20%. | 1 | 7 | 1 | 7 |
|
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| New Infection | Infections and infestations |
|
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