Acute Lung Injury, Acute Respiratory Distress Syndrome, Respiratory Distress Syndrome, Adult
Conditions
Keywords
Respiratory distress syndrome, adult, Acute lung injury, Acute respiratory distress syndrome, ARDS, human, Fish oils, Fatty Acids, Omega-3, Docosahexaenoic Acids, Eicosapentaenoic Acid
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. 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.
Interventions
DRUGFish oil (eicosapentaenoic acid and docosahexanoic acid)
Liquid fish oil 7.5cc enterally every 6 hours
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
American Thoracic Society
Acute Respiratory Distress Syndrome Foundation
American Society for Parenteral and Enteral Nutrition
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Requiring positive-pressure mechanical ventilation * ALI criteria: PaO2/FiO2 \<300, bilateral infiltrates on chest radiograph, no left atrial hypertension * Age \> 17 years
Exclusion criteria
* Expected ICU length of stay \<48 hours * Unable to undergo bronchoalveolar lavage at enrollment * Unable to obtain enteral access * Post-cardiac arrest with suspected significant anoxic brain injury * Expected survival \< 28 days * Pregnant * Platelet count \< 30,000, active bleeding, or international normalized ratio (INR)\>3.0 * History of ventricular tachycardia or fibrillation * Receiving recombinant human activated protein C (rh-APC) for sepsis * Acquired immune deficiency syndrome (AIDS) with CD4 count \< 200 * Metastatic cancer * History of bone marrow, lung, liver, cardiac, kidney, or pancreas transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8 | Days 1 and 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BALF Interleukin-6 | Days 1 and 5 | 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. |
| Change in BALF Monocyte Chemotactic Protein-1 | Days 1 and 5 | 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. |
| Change in BALF Neutrophil Count | Days 1 and 5 | 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. |
| Static Lung Compliance | Day 5 | 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. |
| Oxygenation | Day 5 | 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. |
| Change in Plasma Interleukin-8 | Days 1 and 5 | 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. |
| Change in Plasma Leukotriene B4 | Days 1 and 5 | 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. |
| Change in Plasma Interleukin-6 | Days 1 and 5 | 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. |
| Change in BALF Leukotriene B4 | Days 1 and 5 | 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. |
| Change in Plasma vonWillebrand Factor | Days 1 and 5 | 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. |
| Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment | Throughout hospital stay | 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. |
| Ventilator-free Days During First 28 Days After Study Enrollment | 28 days | 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. |
| ICU-free Days During First 28 Days After Study Enrollment | 28 days | 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. |
| Hospital Length of Stay | At end of hospital admission | — |
| Hospital Mortality | At end of hospitalization | — |
| 60-day Mortality | 60 days from day of enrollment into study | — |
| Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8 | Days 1 and 9 | 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. |
| Change in Plasma Surfactant Protein D | Days 1 and 5 | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enteral Fish Oil 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily | 41 |
| Enteral Saline 7.5cc 0.9% saline every 6 hours | 49 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Extubated before first BAL | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Enteral Fish Oil | Enteral Saline | Total |
|---|---|---|---|
| Age Continuous | 49.0 years STANDARD_DEVIATION 16.5 | 50.7 years STANDARD_DEVIATION 16.5 | 49.9 years STANDARD_DEVIATION 16.4 |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Male | 24 Participants | 33 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 41 | 27 / 49 |
| serious Total, serious adverse events | 12 / 41 | 10 / 49 |
Outcome results
Primary
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
Population: The primary outcome was \>=50% reduction in BALF IL-8, measured as the change from baseline to day 5. With α=0.05 and β=0.2, we calculated that 26 patients per group were needed if participants underwent two BALs. Analysis was intention to treat (ITT).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8 | 43 pg/mL |
| Enteral Saline | Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8 | -241 pg/mL |
p-value: 0.37Wilcoxon (Mann-Whitney)
Secondary
60-day Mortality
Time frame: 60 days from day of enrollment into study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enteral Fish Oil | 60-day Mortality | 9 Participants |
| Enteral Saline | 60-day Mortality | 11 Participants |
p-value: 0.49Chi-squared
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in BALF Interleukin-6 | -24 pg/mL |
| Enteral Saline | Change in BALF Interleukin-6 | -200 pg/mL |
p-value: 0.16Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in BALF Interleukin-6 | -52 pg/mL |
| Enteral Saline | Change in BALF Interleukin-6 | -198 pg/mL |
p-value: 0.84Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in BALF Leukotriene B4 | 0 pg/mL |
| Enteral Saline | Change in BALF Leukotriene B4 | 16 pg/mL |
p-value: 0.38Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in BALF Leukotriene B4 | 6 pg/mL |
| Enteral Saline | Change in BALF Leukotriene B4 | -2 pg/mL |
p-value: 0.04Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in BALF Monocyte Chemotactic Protein-1 | -150 pg/mL |
| Enteral Saline | Change in BALF Monocyte Chemotactic Protein-1 | -226 pg/mL |
p-value: 0.79Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in BALF Monocyte Chemotactic Protein-1 | -402 pg/mL |
| Enteral Saline | Change in BALF Monocyte Chemotactic Protein-1 | -670 pg/mL |
p-value: 0.74Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in BALF Neutrophil Count | -4 # of cells/mm^3 |
| Enteral Saline | Change in BALF Neutrophil Count | -10 # of cells/mm^3 |
p-value: 0.84Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in BALF Neutrophil Count | -3 # of cells/mm^3 |
| Enteral Saline | Change in BALF Neutrophil Count | -10 # of cells/mm^3 |
p-value: 0.34Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8 | -531 pg/mL |
| Enteral Saline | Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8 | -298 pg/mL |
p-value: 0.55Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Plasma Interleukin-6 | -33 pg/mL |
| Enteral Saline | Change in Plasma Interleukin-6 | -78 pg/mL |
p-value: 0.27Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Plasma Interleukin-6 | -83 pg/mL |
| Enteral Saline | Change in Plasma Interleukin-6 | -78 pg/mL |
p-value: 0.86Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Plasma Interleukin-8 | 0 pg/mL |
| Enteral Saline | Change in Plasma Interleukin-8 | 0 pg/mL |
p-value: 0.89Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Plasma Interleukin-8 | -1 pg/mL |
| Enteral Saline | Change in Plasma Interleukin-8 | 0 pg/mL |
p-value: 0.71Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Plasma Leukotriene B4 | 10 pg/mL |
| Enteral Saline | Change in Plasma Leukotriene B4 | 6 pg/mL |
p-value: 0.08Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Plasma Leukotriene B4 | 21 pg/mL |
| Enteral Saline | Change in Plasma Leukotriene B4 | -6 pg/mL |
p-value: 0.002Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Plasma Surfactant Protein D | 26 pg/mL |
| Enteral Saline | Change in Plasma Surfactant Protein D | 17 pg/mL |
p-value: 0.89Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Plasma Surfactant Protein D | 25 pg/mL |
| Enteral Saline | Change in Plasma Surfactant Protein D | 36 pg/mL |
p-value: 0.2Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Plasma vonWillebrand Factor | 116 pg/mL |
| Enteral Saline | Change in Plasma vonWillebrand Factor | 43 pg/mL |
p-value: 0.34Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enteral Fish Oil | Change in Plasma vonWillebrand Factor | 15 pg/mL |
| Enteral Saline | Change in Plasma vonWillebrand Factor | 68 pg/mL |
p-value: 0.11Wilcoxon (Mann-Whitney)
Secondary
Hospital Length of Stay
Time frame: At end of hospital admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enteral Fish Oil | Hospital Length of Stay | 23 Days | Standard Deviation 18.3 |
| Enteral Saline | Hospital Length of Stay | 27.6 Days | Standard Deviation 20.6 |
p-value: 0.27t-test, 2 sided
Secondary
Hospital Mortality
Time frame: At end of hospitalization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enteral Fish Oil | Hospital Mortality | 9 Participants |
| Enteral Saline | Hospital Mortality | 10 Participants |
p-value: 0.65Chi-squared
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enteral Fish Oil | ICU-free Days During First 28 Days After Study Enrollment | 12.2 Days | Standard Deviation 9.8 |
| Enteral Saline | ICU-free Days During First 28 Days After Study Enrollment | 11.2 Days | Standard Deviation 9.7 |
p-value: 0.66t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enteral Fish Oil | Oxygenation | 215.4 PaO2/FiO2 | Standard Deviation 92.8 |
| Enteral Saline | Oxygenation | 174.0 PaO2/FiO2 | Standard Deviation 63.4 |
p-value: 0.06t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enteral Fish Oil | Static Lung Compliance | 31.8 L/cm H20 | Standard Deviation 10.1 |
| Enteral Saline | Static Lung Compliance | 36.3 L/cm H20 | Standard Deviation 20.1 |
p-value: 0.26t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enteral Fish Oil | Ventilator-free Days During First 28 Days After Study Enrollment | 14.5 Days | Standard Deviation 10.3 |
| Enteral Saline | Ventilator-free Days During First 28 Days After Study Enrollment | 13.6 Days | Standard Deviation 9.9 |
p-value: 0.69t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enteral Fish Oil | Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment | 8.5 Scores on a scale | Standard Deviation 3.1 |
| Enteral Saline | Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment | 8.1 Scores on a scale | Standard Deviation 3.3 |
p-value: 0.56t-test, 2 sided