Study:
Prospective, Randomized, Multi-Center Trial of Initial Trophic Enteral Feeding Followed by Advancement to Full-Calorie Enteral Feeding vs. Early Advancement to Full-Calorie Enteral Feeding in Patients With Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) and 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 (ALI) or Acute Respiratory Distress Syndrome (ARDS)
Rationale:
n/a
Purpose:
Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical
conditions that occur when there is severe inflammation and increased fluids in both lungs,
making it difficult for the lungs to function properly. Hospital treatment for a person with
ALI/ARDS often includes the use of a breathing machine, or ventilator, until the person is
able to breathe without assistance. Initiating proper nutrition through a feeding tube early
in a person`s hospital stay may help to improve recovery, but the optimal timing,
composition, and amount of feeding treatments are unknown. This study will evaluate whether
early or delayed full-calorie feeding through a feeding tube is more effective in reducing
recovery time and increasing survival rates in people with ALI/ARDS. The study will also
determine whether supplementing the feedings with omega-3 fatty acids and antioxidants
benefits people with ALI/ARDS.
Study Status: Terminated
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Respiratory Distress Syndrome, Adult |
Behavioral: Minimal (Trophic) Feeding
Behavioral: Full Feeding
Dietary Supplement: Omega-3 Fatty Acids and Antioxidant Supplements
Dietary Supplement: Placebo |
Phase 3 |
Verified by
National Heart, Lung, and Blood Institute (NHLBI)
February, 2012
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov identifier: NCT00609180
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio
United States
Arthur Wheeler, MD., Study Chair