Trial Outcomes & Findings for A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI) (NCT NCT00351533)

NCT ID: NCT00351533

Last Updated: 2011-10-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 90 participants
• Primary outcome timeframe: Days 1 and 5
• Results posted on: 2011-10-03

Participant Flow

Participant milestones

Measure	Enteral Fish Oil 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline 7.5cc 0.9% saline every 6 hours
Overall Study STARTED	41	49
Overall Study COMPLETED	39	44
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Enteral Fish Oil 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline 7.5cc 0.9% saline every 6 hours
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

A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)

Baseline characteristics by cohort

Measure	Enteral Fish Oil n=41 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=49 Participants 7.5cc 0.9% saline every 6 hours	Total n=90 Participants Total of all reporting groups
Age Continuous	49.0 years STANDARD_DEVIATION 16.5 • n=5 Participants	50.7 years STANDARD_DEVIATION 16.5 • n=7 Participants	49.9 years STANDARD_DEVIATION 16.4 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	33 Participants n=7 Participants	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8	43 pg/mL Interval -656.0 to 604.0	-241 pg/mL Interval -807.0 to 349.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Change in BALF Leukotriene B4	6 pg/mL Interval -1.0 to 14.0	-2 pg/mL Interval -26.0 to 9.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Change in BALF Interleukin-6	-24 pg/mL Interval -340.0 to 51.0	-200 pg/mL Interval -692.0 to 0.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Change in BALF Monocyte Chemotactic Protein-1	-150 pg/mL Interval -1812.0 to 93.0	-226 pg/mL Interval -752.0 to -38.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Change in BALF Neutrophil Count	-3 # of cells/mm^3 Interval -19.0 to 12.0	-10 # of cells/mm^3 Interval -21.0 to 7.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Static Lung Compliance	31.8 L/cm H20 Standard Deviation 10.1	36.3 L/cm H20 Standard Deviation 20.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Oxygenation	215.4 PaO2/FiO2 Standard Deviation 92.8	174.0 PaO2/FiO2 Standard Deviation 63.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Change in Plasma Interleukin-8	0 pg/mL Interval -8.0 to 0.0	0 pg/mL Interval -13.0 to 0.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Change in Plasma Leukotriene B4	21 pg/mL Interval 0.0 to 32.0	-6 pg/mL Interval -35.0 to 7.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Change in Plasma Interleukin-6	-33 pg/mL Interval -162.0 to -13.0	-78 pg/mL Interval -163.0 to -29.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Change in Plasma Surfactant Protein D	25 pg/mL Interval 0.0 to 32.0	36 pg/mL Interval 1.0 to 139.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=30 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=36 Participants 7.5cc 0.9% saline every 6 hours
Change in Plasma vonWillebrand Factor	15 pg/mL Interval -103.0 to 158.0	68 pg/mL Interval 21.0 to 206.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=41 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=48 Participants 7.5cc 0.9% saline every 6 hours
Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment	8.5 Scores on a scale Standard Deviation 3.1	8.1 Scores on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=41 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=48 Participants 7.5cc 0.9% saline every 6 hours
Ventilator-free Days During First 28 Days After Study Enrollment	14.5 Days Standard Deviation 10.3	13.6 Days Standard Deviation 9.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=41 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=48 Participants 7.5cc 0.9% saline every 6 hours
ICU-free Days During First 28 Days After Study Enrollment	12.2 Days Standard Deviation 9.8	11.2 Days Standard Deviation 9.7

SECONDARY outcome

Timeframe: At end of hospital admission

Outcome measures

Measure	Enteral Fish Oil n=41 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=48 Participants 7.5cc 0.9% saline every 6 hours
Hospital Length of Stay	23 Days Standard Deviation 18.3	27.6 Days Standard Deviation 20.6

SECONDARY outcome

Timeframe: At end of hospitalization

Outcome measures

Measure	Enteral Fish Oil n=41 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=48 Participants 7.5cc 0.9% saline every 6 hours
Hospital Mortality	9 Participants	10 Participants

SECONDARY outcome

Timeframe: 60 days from day of enrollment into study

Outcome measures

Measure	Enteral Fish Oil n=41 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=45 Participants 7.5cc 0.9% saline every 6 hours
60-day Mortality	9 Participants	11 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=15 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=27 Participants 7.5cc 0.9% saline every 6 hours
Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8	-531 pg/mL Interval -1308.0 to 94.0	-298 pg/mL Interval -870.0 to 397.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=15 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=27 Participants 7.5cc 0.9% saline every 6 hours
Change in BALF Leukotriene B4	0 pg/mL Interval -2.0 to 33.0	16 pg/mL Interval 0.0 to 50.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=15 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=27 Participants 7.5cc 0.9% saline every 6 hours
Change in BALF Interleukin-6	-52 pg/mL Interval -898.0 to 0.0	-198 pg/mL Interval -865.0 to -17.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=15 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=27 Participants 7.5cc 0.9% saline every 6 hours
Change in BALF Monocyte Chemotactic Protein-1	-402 pg/mL Interval -1690.0 to -41.0	-670 pg/mL Interval -1057.0 to -151.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Enteral Fish Oil n=15 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=27 Participants 7.5cc 0.9% saline every 6 hours
Change in BALF Neutrophil Count	-4 # of cells/mm^3 Interval -48.0 to 8.0	-10 # of cells/mm^3 Interval -56.0 to 15.0

SECONDARY outcome

Timeframe: Days 1 and 9

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.

Outcome measures

Measure	Enteral Fish Oil n=15 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=27 Participants 7.5cc 0.9% saline every 6 hours
Change in Plasma Interleukin-8	-1 pg/mL Interval -17.0 to 0.0	0 pg/mL Interval -15.0 to 2.0

SECONDARY outcome

Timeframe: Days 1 and 9

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.

Outcome measures

Measure	Enteral Fish Oil n=15 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=27 Participants 7.5cc 0.9% saline every 6 hours
Change in Plasma Leukotriene B4	10 pg/mL Interval 3.0 to 40.0	6 pg/mL Interval -22.0 to 14.0

SECONDARY outcome

Timeframe: Days 1 and 9

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.

Outcome measures

Measure	Enteral Fish Oil n=15 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=27 Participants 7.5cc 0.9% saline every 6 hours
Change in Plasma Interleukin-6	-83 pg/mL Interval -174.0 to 14.0	-78 pg/mL Interval -163.0 to -29.0

SECONDARY outcome

Timeframe: Days 1 and 9

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.

Outcome measures

Measure	Enteral Fish Oil n=15 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=27 Participants 7.5cc 0.9% saline every 6 hours
Change in Plasma Surfactant Protein D	26 pg/mL Interval -12.0 to 78.0	17 pg/mL Interval -36.0 to 68.0

SECONDARY outcome

Timeframe: Days 1 and 9

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.

Outcome measures

Measure	Enteral Fish Oil n=15 Participants 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=27 Participants 7.5cc 0.9% saline every 6 hours
Change in Plasma vonWillebrand Factor	116 pg/mL Interval -9.0 to 235.0	43 pg/mL Interval -21.0 to 164.0

Adverse Events

Enteral Fish Oil

Serious events: 12 serious events

Other events: 24 other events

Deaths: 0 deaths

Enteral Saline

Serious events: 10 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Enteral Fish Oil n=41 participants at risk 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=49 participants at risk 7.5cc 0.9% saline every 6 hours
Cardiac disorders Atrial fibrillation with rapid ventricular response	4.9% 2/41 • Number of events 2 • 28 days from day of study enrollment	2.0% 1/49 • Number of events 1 • 28 days from day of study enrollment
Renal and urinary disorders Renal failure requiring renal replacement therapy	4.9% 2/41 • Number of events 2 • 28 days from day of study enrollment	4.1% 2/49 • Number of events 2 • 28 days from day of study enrollment
Respiratory, thoracic and mediastinal disorders Pleural and pericardial effusions	2.4% 1/41 • Number of events 1 • 28 days from day of study enrollment	0.00% 0/49 • 28 days from day of study enrollment
Respiratory, thoracic and mediastinal disorders Critical hypoxemia	2.4% 1/41 • Number of events 1 • 28 days from day of study enrollment	4.1% 2/49 • Number of events 2 • 28 days from day of study enrollment
Blood and lymphatic system disorders Trombocytopenia	0.00% 0/41 • 28 days from day of study enrollment	2.0% 1/49 • Number of events 1 • 28 days from day of study enrollment
Hepatobiliary disorders Fulminant liver failure	2.4% 1/41 • Number of events 1 • 28 days from day of study enrollment	0.00% 0/49 • 28 days from day of study enrollment
Eye disorders Right eye blindness after prolonged prone surgery	2.4% 1/41 • Number of events 1 • 28 days from day of study enrollment	0.00% 0/49 • 28 days from day of study enrollment
Nervous system disorders Recurrent falls	0.00% 0/41 • 28 days from day of study enrollment	2.0% 1/49 • Number of events 1 • 28 days from day of study enrollment
Respiratory, thoracic and mediastinal disorders Aspiration with reintubation	0.00% 0/41 • 28 days from day of study enrollment	4.1% 2/49 • Number of events 2 • 28 days from day of study enrollment
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.4% 1/41 • Number of events 1 • 28 days from day of study enrollment	4.1% 2/49 • Number of events 2 • 28 days from day of study enrollment
Infections and infestations Nosocomial sepsis	2.4% 1/41 • Number of events 1 • 28 days from day of study enrollment	2.0% 1/49 • Number of events 1 • 28 days from day of study enrollment
Cardiac disorders PEA arrest	2.4% 1/41 • Number of events 1 • 28 days from day of study enrollment	0.00% 0/49 • 28 days from day of study enrollment
Skin and subcutaneous tissue disorders Erythema multiforme minor	0.00% 0/41 • 28 days from day of study enrollment	2.0% 1/49 • Number of events 1 • 28 days from day of study enrollment
Nervous system disorders Delayed spinal cord contusion and injury	2.4% 1/41 • Number of events 1 • 28 days from day of study enrollment	0.00% 0/49 • 28 days from day of study enrollment
Vascular disorders Severe hypotension	2.4% 1/41 • Number of events 1 • 28 days from day of study enrollment	2.0% 1/49 • Number of events 1 • 28 days from day of study enrollment
Cardiac disorders Pericardial tamponade	2.4% 1/41 • Number of events 1 • 28 days from day of study enrollment	0.00% 0/49 • 28 days from day of study enrollment
Blood and lymphatic system disorders Retroperitoneal hematoma	0.00% 0/41 • 28 days from day of study enrollment	2.0% 1/49 • Number of events 1 • 28 days from day of study enrollment

Other adverse events

Measure	Enteral Fish Oil n=41 participants at risk 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily	Enteral Saline n=49 participants at risk 7.5cc 0.9% saline every 6 hours
Infections and infestations Total Infections	58.5% 24/41 • Number of events 51 • 28 days from day of study enrollment	55.1% 27/49 • Number of events 50 • 28 days from day of study enrollment

Additional Information

Renee Stapleton, MD PhD

University of Vermont

Phone: 802-656-7975

Email: renee.stapleton@uvm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place