Acute Respiratory Distress Network (ARDSNet) Studies 07, 08, 09, 11, and 12 Early Versus Delayed Enteral Feeding to Treat People with Acute Lung Injury or Acute Respiratory Distress Syndrome (EDEN)

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Accession Number
HLB01171414a

Study Type
Clinical Trial

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period
12/2007 – 5/2011

NHLBI Division
DLD

Dataset(s) Last Updated
August 5, 2024

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.

Objectives

To determine if initial lower-volume trophic enteral feeding would increase ventilator-free days (VFDs) and decrease gastrointestinal intolerances compared with initial full enteral feeding.

Background

Mechanically ventilated patients cannot eat normally and if not fed for long periods become malnourished. Because malnutrition is associated with poor outcomes in critically ill patients, artificial nutrition is often provided, especially in those with acute lung injury (ALI) and with expected longer duration of mechanical ventilation. When feasible, enteral nutrition targeting full caloric needs has been advocated over parenteral nutrition. However, feeding intolerance and common care practices often serve as practical barriers to reaching recommended goals.

Although confounded by indication and severity of illness, several observational studies have shown improved clinical outcomes, including fewer infections, shorter duration of mechanical ventilation, and lower mortality for patients receiving a higher percentage of calculated caloric needs. Nonetheless, the best timing, formulation, and amount of enteral nutrition remain unknown.

Participants

Patients within 48 hours of ALI onset who had received mechanical ventilation for less than 72 hours and whose physicians intended to administer enteral nutrition were eligible. ALI was defined by a ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FIO2) of less than 300 (adjusted if altitude exceeded 1000 m) with bilateral pulmonary infiltrates consistent with edema on chest radiograph without clinical evidence of left atrial hypertension.

Design

Participants were randomized, stratified by site and presence of shock at enrollment, to receive either trophic or full enteral feeding for the first 6 days of mechanical ventilation. The initial 272 patients were also simultaneously randomized to a separate trial (the OMEGA study) comparing a nutritional supplement containing omega-3 fatty acids and antioxidants with an isocaloric, isovolemic control in a 2 × 2 factorial design.

The designated feeding strategy was initiated within 6 hours of randomization and continued until death, extubation, or day 6. The care of mechanically ventilated patients still receiving enteral feedings after day 6 was managed according to the full feeding strategy in both groups. In extubated patients who then required reintubation, enteral nutrition was restarted and managed according to the study protocol.

In the full-feeding group, enteral nutrition was initiated at 25 mL/h and advanced to goal rates as quickly as possible. Gastric residual volumes were checked every 6 hours while enteral feeding was increased. Patients randomized to the initial trophic-feeding group had enteral nutrition initiated at 10 mL/h (10-20 kcal/h) for the first 272 patients who also received the omega-3 or control supplement (240 mL volume per day). After the data and safety monitoring board stopped the OMEGA portion of the factorial design, the initial trophic feeding rate was changed to 20 kcal/h to approximate the calories that had been delivered in the OMEGA study. GRVs were checked every 12 hours during trophic feeding. In patients randomized to trophic feeding, enteral nutrition was advanced to full-energy feeding rates following the same protocol used for the full-feeding group if they were still receiving mechanical ventilation at 144 hours.

Conclusions

There was no difference between groups with regard to the primary end point, VFDs to day 28. There also were no differences in 60-day mortality, organ failure−free days, ICU-free days, or the incidence of infection between groups. Similarly, there were no differences between groups in VFDs or survival when analyzed by body mass index category or when subsets of patients with shock or more severe lung injury (acute respiratory distress syndrome) were examined.

JAMA. 2012 Feb 22;307(8):795-803.

Additional Details

Subjects:

Trophic Feeding: 508

Full Feeding: 492

Age:
 EDEN fullEDEN trophicAll
N%N%N%
17-2081.63122.36202.00
21-25183.66203.94383.80
26-30204.07356.89555.50
31-35255.08265.12515.10
36-40367.32326.30686.80
41-45418.33479.25888.80
46-507515.245110.0412612.60
51-558016.266813.3914814.80
56-605110.376212.2011311.30
61-65408.13448.66848.40
65-70387.72377.28757.50
71-75193.86254.92444.40
76-80173.46305.91474.70
81-85163.25122.36282.80
86-8981.6371.38151.50
Sex:
 EDEN fullEDEN trophicAll
N%N%N%
Female24950.6124147.4449049.00
Male24349.3926752.5651051.00
Race:
 EDEN fullEDEN trophicAll
N%N%N%
Not reported183.66275.31454.50
White37576.2238776.1876276.20
African American8016.267915.5515915.90
Other193.86152.95343.40
 EDEN fullEDEN trophicAll
N%N%N%
Hispanic or Latino5811.796011.8111811.80
Not Hispanic or Latino43488.2144888.1988288.20

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:

Plasma, DNA, Urine, BAL

Visits (Vials):

04/05/2024

 

Plasma

DNA

Urine

Bronchial Lavage

Total

Day 0

4,758

892

2,981

12

8,643

Day 3

3,756

0

3,153

1

6,910

Day 6

2,314

0

2,014

0

4,328

Day 12

1,228

0

16

0

1,244

Visits (Subjects):

04/05/2024

 

Plasma

Total number of subjects

Average volume (ml) per subject

Day 0

990

2.46

Day 3

853

3.97

Day 6

605

5.14

Day 12

277

6.03

 

 

DNA

Total number of subjects

Average mass (µg) per subject

Average volume (ml) per subject

Day 0

878

677.04

0.99

 

 

Urine

Total number of subjects

Average volume (ml) per subject

Day 0

941

5.17

Day 3

804

6.44

Day 6

548

5.53

Day 12

4

6.65

 

 

Bronchial Lavage

Total number of subjects

Average volume (ml) per subject

Day 0

4

0.85

Day 3

1

0.15

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Resources Available

Specimens and Study Datasets

Materials Available

Study Documents

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