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We propose a prospective randomized clinical trail to evaluate the impact of intensive medical nutrition therapy (IMNT) in malnourished patients with ARDS on short and long-term outcomes. Participant's (N = 200) will be randomized to receive either standard care (SC e.g. ad lib feeding of standard food) or IMNT provided early as EN and continued as intensive diet therapy tailored to maximize oral intake until hospital discharge. Primary outcomes evaluated include infections while hospitalized, immune parameters (CD4 and CD8 cells, serum IL-10 and leptin levels,l numbers of T regulatory cells and markers for T cell anergy), days on mechanical ventilation, in the ICU and hospital , and changes in fat free mass(measured by dual energy x-ray absorptiometry), weight, muscular weakness (measured as hand grip strength), fatigue (measured as distanced traveled in 6-minute walk) and pulmonary function.
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Acute Respiratory Distress Syndrome
intensive medical nutrition therapy
RUSH University Medical Center
Enrolling by invitation
National Heart, Lung, and Blood Institute (NHLBI)
Published on BioPortfolio: 2014-08-27T03:15:49-0400
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Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...