Acute Respiratory Distress Network (ARDSNet) Studies 07 and 08 Prospective, Randomized, Blinded, Placebo-controlled, Multi-center Trial of Omega-3 Fatty Acid, Gamma-Linolenic Acid, and Anti-Oxidant Supplementation in the Management of Acute Lung Injury or Acute Respiratory Distress Syndrome (Omega) - Catalog
Acute Respiratory Distress Network (ARDSNet) Studies 07 and 08 Prospective, Randomized, Blinded, Placebo-controlled, Multi-center Trial of Omega-3 Fatty Acid, Gamma-Linolenic Acid, and Anti-Oxidant Supplementation in the Management of Acute Lung Injury or Acute Respiratory Distress Syndrome (Omega)
ARDSNet-Omega
False
True
True
Coded
http://www.ardsnet.org/
False
Clinical Trial
Behavioral: Minimal (Trophic) FeedingBehavioral: Full FeedingDietary Supplement: Omega-3 Fatty Acids and Antioxidant SupplementsDietary Supplement: Placebo
Open Period
2014-10-07
2014-10-07
2014-10-03
2014-10-03
12/2007 – 04/2009
DLD
---------
non-HIV
0
0
No
No
Yes
Yes
Yes, For Some Specimens
Yes
Non-genetic use of biospecimens is restricted to research involving lung injury, other lung disease or critical care diseases. Use of biospecimens in genetic research is tiered to (1) research in acute respiratory distress syndrome (ARDS), or (2) research in other medical conditions. Biospecimens cannot be used directly to produce commercial products.
ALI
ARDS
Acute Lung Injury
Lung Diseases
Respiratory Distress Syndrome, Adult
To determine if dietary supplementation of omega-3 (n-3) fatty acids, γ-linolenic acid and antioxidants to patients with acute lung injury would increase ventilator-free days to study day 28.
Early acute lung injury (ALI) is characterized by neutrophilic lung inflammation, permeability,and intravascular and alveolar fibrin deposition. The type and inflammatory activity of eicosanoids liberated during inflammation depends on the membrane phospholipid composition: omega 6 (n-6) fatty acid arachidonate yields highly reactive and inflammatory dienoic prostaglandins and series 4 leukotrienes, whereas omega-3 (n-3) fatty acids favor production of less active and potentially anti-inflammatory trienoic prostaglandins and series 5 leukotrienes. Patients at risk of developing ALI have n-3 levels approximately 25% of normal and those with established ALI have n-3 levels as low as 6% of normal, suggesting a potential role for n-3 dietary supplementation in patients with ALI.
Three randomized controlled studies, conducted in patients with ALI or sepsis-induced respiratory failure, demonstrated an association between the administration of an enteral formula enriched in n-3 fatty acids, GLA, and antioxidants and improved oxygenation and respiratory physiology compared with an unenriched, high-fat formula. However, interpretation of these results is limited by the small sample sizes and as-treated analyses of only those patients who tolerated full enteral nutrition.
Patients with ALI requiring mechanical ventilation whose physicians intended to start enteral nutrition were eligible for inclusion. Specifically, patients had to be receiving mechanical ventilation, have a ratio of partial pressure of arterial oxygen (PaO2) to fraction of inspired oxygen (FIO2) of less than 300 (adjusted if altitude exceeded 1000 m), and have bilateral pulmonary infiltrates consistent with edema on chest radiograph without clinical evidence of left atrial hypertension. Severe chronic lung disease, ALI present greater than 48 hours, mechanical ventilation for longer than 72 hours, and inability to obtain consent were the most frequent exclusions.
Patients were stratified by hospital and the presence of shock at baseline and then randomized to receive either twice-daily enteral supplementation of n-3 fatty acids, GLA, and antioxidants (n-3 supplement) or an isocaloric-isovolemic carbohydrate-rich control. Participants were also simultaneously randomized to a separate ongoing trial (the EDEN study) comparing low- vs full-calorie enteral nutrition in a 2 × 2 factorial design.
The n-3 or control supplement was administered enterally as twice-daily boluses of 120 mL beginning within 6 hours of randomization. Dosing continued until the earliest of 21 days, 48 hours of unassisted breathing, or extubation. The energy provided by the boluses supplemented that provided by each primary physician's choice of standard continuous non–n-3-enriched enteral formula. The rate of continuous enteral feeding was managed by a protocol with an algorithm for gastrointestinal intolerances. The supplement was administered even if enteral nutrition was interrupted, as long as the patient was tolerating enteral medications.
The study was stopped by the DSMB for futility at the first interim analysis after 143 patients had been randomized to receive the n-3 supplement and 129 to receive the isocaloric control. Despite an 8-fold increase in plasma eicosapentaenoic acid levels, patients receiving the n-3 supplement had fewer ventilator-free days, intensive care unit–free days, and nonpulmonary organ failure-free days.
JAMA. 2011 Oct 12;306(14):1574-81.
BRONCHIAL LAVAGE;PLASMA;URINE
None
-
Subjects
n-3 oil: 143
Placebo: 129
Last Modified: Aug. 28, 2015, 10:42 a.m. -
Age
Omega oil
Omega placebo
All
N
%
N
%
N
%
17-20
1
0.70
2
1.55
3
1.10
21-25
3
2.10
8
6.20
11
4.04
26-30
6
4.20
6
4.65
12
4.41
31-35
11
7.69
4
3.10
15
5.51
36-40
6
4.20
11
8.53
17
6.25
41-45
16
11.19
7
5.43
23
8.46
46-50
14
9.79
11
8.53
25
9.19
51-55
17
11.89
24
18.60
41
15.07
56-60
12
8.39
16
12.40
28
10.29
61-65
13
9.09
11
8.53
24
8.82
65-70
15
10.49
10
7.75
25
9.19
71-75
8
5.59
5
3.88
13
4.78
76-80
8
5.59
8
6.20
16
5.88
81-85
8
5.59
4
3.10
12
4.41
86-89
5
3.50
2
1.55
7
2.57
Last Modified: Aug. 28, 2015, 10:42 a.m. -
Sex
Omega oil
Omega placebo
All
N
%
N
%
N
%
Female
68
47.55
65
50.39
133
48.90
Male
75
52.45
64
49.61
139
51.10
Last Modified: Aug. 28, 2015, 10:42 a.m. -
Race
Omega oil
Omega placebo
All
N
%
N
%
N
%
Not reported
4
2.80
4
3.10
8
2.94
White
106
74.13
104
80.62
210
77.21
African American
27
18.88
19
14.73
46
16.91
Other
6
4.20
2
1.55
8
2.94
Omega oil
Omega placebo
All
N
%
N
%
N
%
Hispanic or Latino
7
4.90
16
12.40
23
8.46
Not Hispanic or Latino
136
95.10
113
87.60
249
91.54
Last Modified: Aug. 28, 2015, 10:42 a.m.
Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process
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Material Types
-
General Freeze/Thaw Status
-
Visits (Vials)
Last Modified: Dec. 5, 2016, 1:12 p.m. -
Visits (Subjects)
12/05/2016
Plasma Total number of subjects Average volume (ml) per subject Day 0 269 3.56 Day 3 233 3.54 Day 6 167 3.77 Day 12 77 5.80 Urine Total number of subjects Average volume (ml) per subject Day 0 247 1.40 Day 3 218 6.28 Day 6 151 2.79 Day 12 1 5.60 Bronchial Lavage Total number of subjects Average volume (ml) per subject Day 0 3 0.67 Day 3 1 0.15
Last Modified: Dec. 5, 2016, 1:12 p.m.