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)

HLB01171414a

ARDSNet-EDEN

False

Released

True

True

Coded

http://www.ardsnet.org/

False

Clinical Trial

Open BioLINCC Study

Adult

Behavioral: Minimal (Trophic) FeedingBehavioral: Full Feeding

2014-10-07

2014-10-07

2014-10-02

2014-10-02

12/2007 – 5/2011

DLD

Lung

non-HIV

non-COVID

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

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.

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.

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.

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.

Bronchial Lavage
DNA
Plasma
Urine

Acute Respiratory Distress Network (ARDSNet)