A Phase 2 interventional study of Fish oil (eicosapentaenoic acid and docosahexanoic acid) in Respiratory Distress Syndrome, Adult, Acute Lung Injury and Acute Respiratory Distress Syndrome, sponsored by University of Washington. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-03.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
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.
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.
Comparison(s): 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.
1,619 studies on the registry are indexed under Respiratory Distress Syndrome; 319 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 973 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Exclusion Criteria:
Enteral fish oil
Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)
Enteral saline
Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)
Drug page: Fish Oils
Liquid fish oil 7.5cc enterally every 6 hours
Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 5
Change in BALF Leukotriene B4
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 5
Change in BALF Interleukin-6
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 5
Change in BALF Monocyte Chemotactic Protein-1
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 5
Change in BALF Neutrophil Count
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 5
Static Lung Compliance
30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.
Time frame: Day 5
Oxygenation
PaO2/FiO2 is the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen. 30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.
Time frame: Day 5
Change in Plasma Interleukin-8
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 5
Change in Plasma Leukotriene B4
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 5
Change in Plasma Interleukin-6
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 5
Change in Plasma Surfactant Protein D
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 5
Change in Plasma vonWillebrand Factor
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 5
Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment
Full scale name is Multiple Organ Dysfunction Score (MODS), a scale measuring degree of organ dysfunction in critically ill patients. Minimum score is 0 and maximum score is 24, with 0 indicating no organ failure and 24 indicating severe failure of multiple organs.
Time frame: Throughout hospital stay
Ventilator-free Days During First 28 Days After Study Enrollment
Ventilator-free days is a common outcome measure in critical care research. A ventilator-free day is a day that a participant is alive and not receiving mechanical ventilation during the first 28 days after s/he enrolled in the study.
Time frame: 28 days
ICU-free Days During First 28 Days After Study Enrollment
ICU-free days is a common outcome measure in critical care research. An ICU-free day is a day that a participant is alive and not in the intensive care unit (ICU) during the first 28 days after s/he enrolled in the study.
Time frame: 28 days
Hospital Length of Stay
Time frame: At end of hospital admission
Hospital Mortality
Time frame: At end of hospitalization
60-day Mortality
Time frame: 60 days from day of enrollment into study
Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 9
Change in BALF Leukotriene B4
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 9
Change in BALF Interleukin-6
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 9
Change in BALF Monocyte Chemotactic Protein-1
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 9
Change in BALF Neutrophil Count
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 9
Change in Plasma Interleukin-8
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 9
Change in Plasma Leukotriene B4
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 9
Change in Plasma Interleukin-6
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 9
Change in Plasma Surfactant Protein D
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 9
Change in Plasma vonWillebrand Factor
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Time frame: Days 1 and 9
| Milestone | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Started | 41 | 49 |
| Completed | 39 | 44 |
| Not completed | 2 | 5 |
| Withdrew: Extubated before first bal | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8 | 43 (-656 to 604) | -241 (-807 to 349) |
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in BALF Leukotriene B4 | 6 (-1 to 14) | -2 (-26 to 9) |
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in BALF Interleukin-6 | -24 (-340 to 51) | -200 (-692 to 0) |
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in BALF Monocyte Chemotactic Protein-1 | -150 (-1812 to 93) | -226 (-752 to -38) |
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
| # of cells/mm^3 | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in BALF Neutrophil Count | -3 (-19 to 12) | -10 (-21 to 7) |
30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.
| L/cm H20 | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Static Lung Compliance | 31.8 ± 10.1 | 36.3 ± 20.1 |
PaO2/FiO2 is the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen. 30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.
| PaO2/FiO2 | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Oxygenation | 215.4 ± 92.8 | 174.0 ± 63.4 |
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Plasma Interleukin-8 | 0 (-8 to 0) | 0 (-13 to 0) |
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Plasma Leukotriene B4 | 21 (0 to 32) | -6 (-35 to 7) |
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Plasma Interleukin-6 | -33 (-162 to -13) | -78 (-163 to -29) |
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Plasma Surfactant Protein D | 25 (0 to 32) | 36 (1 to 139) |
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Plasma vonWillebrand Factor | 15 (-103 to 158) | 68 (21 to 206) |
Full scale name is Multiple Organ Dysfunction Score (MODS), a scale measuring degree of organ dysfunction in critically ill patients. Minimum score is 0 and maximum score is 24, with 0 indicating no organ failure and 24 indicating severe failure of multiple organs.
| Scores on a scale | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment | 8.5 ± 3.1 | 8.1 ± 3.3 |
Ventilator-free days is a common outcome measure in critical care research. A ventilator-free day is a day that a participant is alive and not receiving mechanical ventilation during the first 28 days after s/he enrolled in the study.
| Days | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Ventilator-free Days During First 28 Days After Study Enrollment | 14.5 ± 10.3 | 13.6 ± 9.9 |
ICU-free days is a common outcome measure in critical care research. An ICU-free day is a day that a participant is alive and not in the intensive care unit (ICU) during the first 28 days after s/he enrolled in the study.
| Days | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| ICU-free Days During First 28 Days After Study Enrollment | 12.2 ± 9.8 | 11.2 ± 9.7 |
| Days | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Hospital Length of Stay | 23 ± 18.3 | 27.6 ± 20.6 |
| Participants | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Hospital Mortality | 9 | 10 |
| Participants | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| 60-day Mortality | 9 | 11 |
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8 | -531 (-1308 to 94) | -298 (-870 to 397) |
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in BALF Leukotriene B4 | 0 (-2 to 33) | 16 (0 to 50) |
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in BALF Interleukin-6 | -52 (-898 to 0) | -198 (-865 to -17) |
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in BALF Monocyte Chemotactic Protein-1 | -402 (-1690 to -41) | -670 (-1057 to -151) |
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
| # of cells/mm^3 | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in BALF Neutrophil Count | -4 (-48 to 8) | -10 (-56 to 15) |
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Plasma Interleukin-8 | -1 (-17 to 0) | 0 (-15 to 2) |
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Plasma Leukotriene B4 | 10 (3 to 40) | 6 (-22 to 14) |
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Plasma Interleukin-6 | -83 (-174 to 14) | -78 (-163 to -29) |
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Plasma Surfactant Protein D | 26 (-12 to 78) | 17 (-36 to 68) |
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
| pg/mL | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Change in Plasma vonWillebrand Factor | 116 (-9 to 235) | 43 (-21 to 164) |
Collected over 28 days from day of study enrollment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enteral Fish Oil | — | 12/41 (29.3%) | 24/41 (58.5%) |
| Enteral Saline | — | 10/49 (20.4%) | 27/49 (55.1%) |
| Event | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Atrial fibrillation with rapid ventricular responseCardiac disorders | 2/41 | 1/49 |
| Renal failure requiring renal replacement therapyRenal and urinary disorders | 2/41 | 2/49 |
| Critical hypoxemiaRespiratory, thoracic and mediastinal disorders | 1/41 | 2/49 |
| Aspiration with reintubationRespiratory, thoracic and mediastinal disorders | 0/41 | 2/49 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/41 | 2/49 |
| Pleural and pericardial effusionsRespiratory, thoracic and mediastinal disorders | 1/41 | 0/49 |
| Fulminant liver failureHepatobiliary disorders | 1/41 | 0/49 |
| Right eye blindness after prolonged prone surgeryEye disorders | 1/41 | 0/49 |
| Nosocomial sepsisInfections and infestations | 1/41 | 1/49 |
| PEA arrestCardiac disorders | 1/41 | 0/49 |
| Event | Enteral Fish Oil | Enteral Saline |
|---|---|---|
| Total InfectionsInfections and infestations | 24/41 | 27/49 |
| Age Continuous(years) | Enteral Fish Oil | Enteral Saline | Total |
|---|---|---|---|
| Mean | 49.0 ± 16.5 | 50.7 ± 16.5 | 49.9 ± 16.4 |
| Sex: Female, Male(Participants) | Enteral Fish Oil | Enteral Saline | Total |
|---|---|---|---|
| Female | 17 | 16 | 33 |
| Male | 24 | 33 | 57 |
The record gives a start of Jul 2006, a primary completion of Jan 2009 and a completion of Aug 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2011, 2 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Fish Oils
Respiratory Distress Syndrome →