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Home > Studies > ARDSNet-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) - Catalog

Basic Study Information

Name

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)

Accession Number

HLB01181414a

Acronym

ARDSNet-Omega

BSI Study IDs

AR7

AR8 (Not Included in Utilization Report)

Is public use dataset

False

Keywords

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

http://www.ardsnet.org/

The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

False

Clinical Trial URLs
https://clinicaltrials.gov/show/NCT00609180
Study type

Clinical Trial

Interventions

Behavioral: Minimal (Trophic) FeedingBehavioral: Full FeedingDietary Supplement: Omega-3 Fatty Acids and Antioxidant SupplementsDietary Supplement: Placebo

Collection Type

Open BioLINCC Study

Study Open Date (Data)

2014-10-07

Study Open Date (Specimens)

2014-10-07

Date prepared

2014-10-03

Last updated

2014-10-03

Study period

12/2007 – 04/2009

Study Contacts
NHLBI Division

DLD

Classification

Lung

HIV study classification

non-HIV

Year(s) Reviewed by BCRP

Pre-Website # of Specimens Shipped

0

# of Returned Specimens

0

Primary Publication URLs
http://www.ncbi.nlm.nih.gov/pubmed/21976613

Study Consent

Commercial use data restrictions

No

Data restrictions based on area of research

No

Commercial use specimen restrictions

Yes

Non-genetic use specimen restrictions based on area of use

Yes

Genetic use of specimens allowed?

Yes, For Some Specimens

Genetic use area of research restrictions

Yes

Specific Consent Restrictions

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.

Additional Study Information

Conditions

ALI
ARDS
Acute Lung Injury
Lung Diseases
Respiratory Distress Syndrome, Adult

Objectives

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.

Background

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.

Subjects

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.

Design

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.

Conclusions

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.

Disease classification

Publications

Material Types

Bronchial Lavage
Plasma
Urine

Study Population

  • 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.

Available Biospecimens

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

  • Material Types
  • General Freeze/Thaw Status
  • Visits (Vials)

    03/08/2021

      Plasma Urine Bronchial Lavage Total
    Day 0 919 256 6 1,181
    Day 3 859 864 1 1,724
    Day 6 544 448 0 992
    Day 12 441 4 0 445

     

    Last Modified: March 8, 2021, 4:28 p.m.
  • Visits (Subjects)

    03/08/2021

      Plasma
    Total number of subjects Average volume (ml) per subject
    Day 0 269 2.55
    Day 3 233 3.16
    Day 6 167 3.36
    Day 12 77 5.41
     
      Urine
    Total number of subjects Average volume (ml) per subject
    Day 0 247 1.40
    Day 3 218 6.28
    Day 6 151 2.67
    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: March 8, 2021, 4:28 p.m.
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