Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351533
Status:
COMPLETED
Last Update Posted:
2011-10-03
First Post:
2006-07-11
Brief Title:
A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury ALI
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Randomized Double-blind Study of the Effect of Fish Oil Eicosapentaenoic Acid and Docosahexanoic Acid on Lung and Systemic Inflammation in Patients With Acute Lung Injury ALI
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether fish oil containing omega-3 fatty acids given enterally is safe and effective in reducing lung and systemic inflammation seen in acute lung injury
Detailed Description:
Acute lung injury ALI is common among critically ill patients and is associated with a high case fatality Only one intervention has been shown to improve survival in a large clinical trial and new therapies targeting the inflammatory response are needed Nutrient interventions may provide benefit specifically there is plausible biologic rationale for administering n-3 fatty acids n-3 FAs found in fish oil to patients with ALI as n-3 FAs decrease formation of eicosanoid inflammatory mediators However although promising results have emerged from prior studies fish oils have only been tested in ALI patients in a commercial enteral formula containing additional nutrients and the control group received a high-fat enteral formula that may have been proinflammatory Therefore no conclusion can be drawn about the independent effect of fish oils Furthermore the inclusion of key pharmaconutrients in feeding formulas instead of delivering them separately as pharmaceuticals limits exposure to the agent as intensive care unit ICU patients commonly receive less than 60 of prescribed caloric needs Finally specialized feeding formulas are very expensive and it may be substantially cheaper to administer pharmaconutrients separately We believe it is time to begin to approach nutrient trials in critically ill patients differently -- to move away from including them in feeding formulas and begin delivering them like pharmaceuticals With appropriate scientific investigation and the use of non-nutrient placebos this novel and innovative approach is a new paradigm of investigating nutrient delivery to critically ill patients
This study is a phase II randomized controlled trial to determine the effects of enteral eicosapentaenoic acid EPA and docosahexanoic acid DHA both n-3 FAs found in fish oil versus placebo on the pulmonary and systemic environments and on clinical outcomes in patients with ALI We will investigate the effect of fish oil administration on several biological markers of injury and inflammation in bronchoalveolar lavage fluid and serum on pulmonary physiologic outcomes and on clinical outcomes
Comparisons Mechanically ventilated patients with acute lung injury randomized to receive enteral fish oil versus compared to mechanically ventilated patients with acute lung injury randomized to receive placebo
This study is a phase II randomized controlled trial to determine the effects of enteral eicosapentaenoic acid EPA and docosahexanoic acid DHA both n-3 FAs found in fish oil versus placebo on the pulmonary and systemic environments and on clinical outcomes in patients with ALI We will investigate the effect of fish oil administration on several biological markers of injury and inflammation in bronchoalveolar lavage fluid and serum on pulmonary physiologic outcomes and on clinical outcomes
Comparisons Mechanically ventilated patients with acute lung injury randomized to receive enteral fish oil versus compared to mechanically ventilated patients with acute lung injury randomized to receive placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-7895-A 03 | None | None | None |