A Phase II Randomized Trial of Fish Oil in Patients With... | NCT00351533

ID	Type	Description	Link
05-7895-A 03

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH
American Thoracic Society	OTHER
Acute Respiratory Distress Syndrome Foundation	OTHER

Label	Type	Description	Intervention Names
1	Experimental	Enteral fish oil	Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)
2	Placebo Comparator	Enteral saline	Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)

Name	Type	Description	Arm Group Labels	Other Names
Fish oil (eicosapentaenoic acid and docosahexanoic acid)	Drug	Liquid fish oil 7.5cc enterally every 6 hours	1 2

Measure	Description	Time Frame
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.	Days 1 and 5

Measure	Description	Time Frame
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.	Days 1 and 5

Name	Affiliation	Role
Renee D. Stapleton, MD, MSc	University of Vermont	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
St. Alphonsus Medical Center		Boise	Idaho	83706	United States
Oregon Health Sciences University

ID	Title	Description
FG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
FG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

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.

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).

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG00030 OG00136

Title

Denominators

Categories

Title	Measurements
	OG00043(-656 to 604) OG001-241(-807 to 349)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		0.37							95						No	Superiority or Other

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

# of cells/mm^3

Days 1 and 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

L/cm H20

Day 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

PaO2/FiO2

Day 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 5

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

Scores on a scale

Throughout hospital stay

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

Days

28 days

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

Days

28 days

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

Secondary

Hospital Length of Stay

Posted

Mean

Standard Deviation

Days

At end of hospital admission

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG00041 OG001

Secondary

Hospital Mortality

Posted

Number

Participants

At end of hospitalization

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG00041 OG001

Secondary

60-day Mortality

Posted

Number

Participants

60 days from day of enrollment into study

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG00041 OG001

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 9

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 9

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 9

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 9

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

# of cells/mm^3

Days 1 and 9

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 9

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 9

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 9

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 9

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

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.

Posted

Median

Inter-Quartile Range

pg/mL

Days 1 and 9

ID	Title	Description
OG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
OG001	Enteral Saline	7.5cc 0.9% saline every 6 hours

Units	Counts
Participants	OG000

Term	Organ System	Statistical Information
Atrial fibrillation with rapid ventricular response	Cardiac disorders	EG0002 events2 affected41 at risk EG0011 events1 affected49 at risk
Renal failure requiring renal replacement therapy	Renal and urinary disorders	EG0002 events2 affected41 at risk EG0012 events2 affected49 at risk
Pleural and pericardial effusions	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected41 at risk EG0010 events0 affected49 at risk
Critical hypoxemia	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected41 at risk EG0012 events2 affected49 at risk
Trombocytopenia	Blood and lymphatic system disorders	EG0000 events0 affected41 at risk EG0011 events1 affected49 at risk
Fulminant liver failure	Hepatobiliary disorders	EG0001 events1 affected41 at risk EG0010 events0 affected49 at risk
Right eye blindness after prolonged prone surgery	Eye disorders	EG0001 events1 affected41 at risk EG0010 events0 affected49 at risk
Recurrent falls	Nervous system disorders	EG0000 events0 affected41 at risk EG0011 events1 affected49 at risk
Aspiration with reintubation	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected41 at risk EG0012 events2 affected49 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected41 at risk EG0012 events2 affected49 at risk
Nosocomial sepsis	Infections and infestations	EG0001 events1 affected41 at risk EG0011 events1 affected49 at risk
PEA arrest	Cardiac disorders	EG0001 events1 affected41 at risk EG0010 events0 affected49 at risk
Erythema multiforme minor	Skin and subcutaneous tissue disorders	EG0000 events0 affected41 at risk EG0011 events1 affected49 at risk
Delayed spinal cord contusion and injury	Nervous system disorders	EG0001 events1 affected41 at risk EG0010 events0 affected49 at risk
Severe hypotension	Vascular disorders	EG0001 events1 affected41 at risk EG0011 events1 affected49 at risk
Pericardial tamponade	Cardiac disorders	EG0001 events1 affected41 at risk EG0010 events0 affected49 at risk
Retroperitoneal hematoma	Blood and lymphatic system disorders	EG0000 events0 affected41 at risk EG0011 events1 affected49 at risk

ID	Term
D012128	Respiratory Distress Syndrome
D055371	Acute Lung Injury

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D055370	Lung Injury

ID	Term
D005395	Fish Oils
D015118	Eicosapentaenoic Acid

ID	Term
D009821	Oils
D008055	Lipids
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids

ID	Title	Description
BG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
BG001	Enteral Saline	7.5cc 0.9% saline every 6 hours
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Enteral Fish Oil	7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily			12	41	24	41
EG001	Enteral Saline	7.5cc 0.9% saline every 6 hours			10	49	27	49