Intensive Nutrition in Acute Respiratory Distress Syndrome (ARDS): A Clinical Trial (INTACT)

Stopped early · Not applicable

Conditions studied: Acute Lung Injury

In brief

The investigators propose a prospective randomized clinical trail to evaluate the impact of intensive medical nutrition therapy (IMNT) in patients with acute respiratory distress syndrome (ARDS) or acute lung injury (ALI) 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 enteral nutrition (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, 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.

Key facts

Study ID
NCT01921101
Run by
University of Illinois at Chicago
People needed
78
Starts
2009-07-01
Expected to finish
2013-06-01
Last updated by the study team
2014-08-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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