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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00351533
Recruitment Status : Completed
First Posted : July 13, 2006
Results First Posted : October 3, 2011
Last Update Posted : October 3, 2011
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Thoracic Society
Acute Respiratory Distress Syndrome Foundation
American Society for Parenteral and Enteral Nutrition
Information provided by (Responsible Party):
Renee Stapleton, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Respiratory Distress Syndrome, Adult
Acute Lung Injury
Acute Respiratory Distress Syndrome
Intervention Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily 7.5cc 0.9% saline every 6 hours
Period Title: Overall Study
Started 41 49
Completed 39 [1] 44 [1]
Not Completed 2 5
Reason Not Completed
Extubated before first BAL             1             0
Lost to Follow-up             1             3
Physician Decision             0             1
Withdrawal by Subject             0             1
[1]
Pts did not undergo BALs if not intubated
Arm/Group Title Enteral Fish Oil Enteral Saline Total
Hide Arm/Group Description 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily 7.5cc 0.9% saline every 6 hours Total of all reporting groups
Overall Number of Baseline Participants 41 49 90
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 49 participants 90 participants
49.0  (16.5) 50.7  (16.5) 49.9  (16.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 49 participants 90 participants
Female
17
  41.5%
16
  32.7%
33
  36.7%
Male
24
  58.5%
33
  67.3%
57
  63.3%
1.Primary Outcome
Title Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
43
(-656 to 604)
-241
(-807 to 349)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in BALF Leukotriene B4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
6
(-1 to 14)
-2
(-26 to 9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Change in BALF Interleukin-6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-24
(-340 to 51)
-200
(-692 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Change in BALF Monocyte Chemotactic Protein-1
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-150
(-1812 to 93)
-226
(-752 to -38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Change in BALF Neutrophil Count
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Median (Inter-Quartile Range)
Unit of Measure: # of cells/mm^3
-3
(-19 to 12)
-10
(-21 to 7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Static Lung Compliance
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Mean (Standard Deviation)
Unit of Measure: L/cm H20
31.8  (10.1) 36.3  (20.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Oxygenation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Mean (Standard Deviation)
Unit of Measure: PaO2/FiO2
215.4  (92.8) 174.0  (63.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Change in Plasma Interleukin-8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
0
(-8 to 0)
0
(-13 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Change in Plasma Leukotriene B4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
21
(0 to 32)
-6
(-35 to 7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Change in Plasma Interleukin-6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-33
(-162 to -13)
-78
(-163 to -29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Change in Plasma Surfactant Protein D
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
25
(0 to 32)
36
(1 to 139)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Change in Plasma vonWillebrand Factor
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 30 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
15
(-103 to 158)
68
(21 to 206)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 41 48
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
8.5  (3.1) 8.1  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title Ventilator-free Days During First 28 Days After Study Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 41 48
Mean (Standard Deviation)
Unit of Measure: Days
14.5  (10.3) 13.6  (9.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Secondary Outcome
Title ICU-free Days During First 28 Days After Study Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 41 48
Mean (Standard Deviation)
Unit of Measure: Days
12.2  (9.8) 11.2  (9.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Secondary Outcome
Title Hospital Length of Stay
Hide Description [Not Specified]
Time Frame At end of hospital admission
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 41 48
Mean (Standard Deviation)
Unit of Measure: Days
23  (18.3) 27.6  (20.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Hospital Mortality
Hide Description [Not Specified]
Time Frame At end of hospitalization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 41 48
Measure Type: Number
Unit of Measure: Participants
9 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
18.Secondary Outcome
Title 60-day Mortality
Hide Description [Not Specified]
Time Frame 60 days from day of enrollment into study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 41 45
Measure Type: Number
Unit of Measure: Participants
9 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
19.Secondary Outcome
Title Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 15 27
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-531
(-1308 to 94)
-298
(-870 to 397)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
20.Secondary Outcome
Title Change in BALF Leukotriene B4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 15 27
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
0
(-2 to 33)
16
(0 to 50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
21.Secondary Outcome
Title Change in BALF Interleukin-6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 15 27
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-52
(-898 to 0)
-198
(-865 to -17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
22.Secondary Outcome
Title Change in BALF Monocyte Chemotactic Protein-1
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 15 27
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-402
(-1690 to -41)
-670
(-1057 to -151)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
23.Secondary Outcome
Title Change in BALF Neutrophil Count
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 15 27
Median (Inter-Quartile Range)
Unit of Measure: # of cells/mm^3
-4
(-48 to 8)
-10
(-56 to 15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
24.Secondary Outcome
Title Change in Plasma Interleukin-8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 15 27
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-1
(-17 to 0)
0
(-15 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
25.Secondary Outcome
Title Change in Plasma Leukotriene B4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 15 27
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
10
(3 to 40)
6
(-22 to 14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
26.Secondary Outcome
Title Change in Plasma Interleukin-6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 15 27
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-83
(-174 to 14)
-78
(-163 to -29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
27.Secondary Outcome
Title Change in Plasma Surfactant Protein D
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 15 27
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
26
(-12 to 78)
17
(-36 to 68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
28.Secondary Outcome
Title Change in Plasma vonWillebrand Factor
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description:
7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
7.5cc 0.9% saline every 6 hours
Overall Number of Participants Analyzed 15 27
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
116
(-9 to 235)
43
(-21 to 164)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteral Fish Oil, Enteral Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 28 days from day of study enrollment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enteral Fish Oil Enteral Saline
Hide Arm/Group Description 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily 7.5cc 0.9% saline every 6 hours
All-Cause Mortality
Enteral Fish Oil Enteral Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Enteral Fish Oil Enteral Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/41 (29.27%)      10/49 (20.41%)    
Blood and lymphatic system disorders     
Trombocytopenia  0/41 (0.00%)  0 1/49 (2.04%)  1
Retroperitoneal hematoma  0/41 (0.00%)  0 1/49 (2.04%)  1
Cardiac disorders     
Atrial fibrillation with rapid ventricular response  2/41 (4.88%)  2 1/49 (2.04%)  1
PEA arrest  1/41 (2.44%)  1 0/49 (0.00%)  0
Pericardial tamponade  1/41 (2.44%)  1 0/49 (0.00%)  0
Eye disorders     
Right eye blindness after prolonged prone surgery  1/41 (2.44%)  1 0/49 (0.00%)  0
Hepatobiliary disorders     
Fulminant liver failure  1/41 (2.44%)  1 0/49 (0.00%)  0
Infections and infestations     
Nosocomial sepsis  1/41 (2.44%)  1 1/49 (2.04%)  1
Nervous system disorders     
Recurrent falls  0/41 (0.00%)  0 1/49 (2.04%)  1
Delayed spinal cord contusion and injury  1/41 (2.44%)  1 0/49 (0.00%)  0
Renal and urinary disorders     
Renal failure requiring renal replacement therapy  2/41 (4.88%)  2 2/49 (4.08%)  2
Respiratory, thoracic and mediastinal disorders     
Pleural and pericardial effusions  1/41 (2.44%)  1 0/49 (0.00%)  0
Critical hypoxemia  1/41 (2.44%)  1 2/49 (4.08%)  2
Aspiration with reintubation  0/41 (0.00%)  0 2/49 (4.08%)  2
Pneumothorax  1/41 (2.44%)  1 2/49 (4.08%)  2
Skin and subcutaneous tissue disorders     
Erythema multiforme minor  0/41 (0.00%)  0 1/49 (2.04%)  1
Vascular disorders     
Severe hypotension  1/41 (2.44%)  1 1/49 (2.04%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enteral Fish Oil Enteral Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/41 (58.54%)      27/49 (55.10%)    
Infections and infestations     
Total Infections  24/41 (58.54%)  51 27/49 (55.10%)  50
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Renee Stapleton, MD PhD
Organization: University of Vermont
Phone: 802-656-7975
Responsible Party: Renee Stapleton, University of Washington
ClinicalTrials.gov Identifier: NCT00351533     History of Changes
Other Study ID Numbers: 28503-A
05-7895-A 03
First Submitted: July 11, 2006
First Posted: July 13, 2006
Results First Submitted: February 16, 2011
Results First Posted: October 3, 2011
Last Update Posted: October 3, 2011