NCT01921101

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

Intensive Nutrition in ARDS: A Clinical Trail (INTACT)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study was terminated early due to greater deaths occurring in the intervention group vs the control group. There were a total of 22 deaths, 16 in the intervention and 6 in the control.

Conditions

• Acute Lung Injury

Interventions

Type	Name	Description
BEHAVIORAL	intensive medical nutrition	provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge
OTHER	control	participants will receive standard care for nutrition received from hospital admission to discharge

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-08-13
• Last updated: 2014-08-06
• Results posted: 2014-05-14

Locations

1 site across 1 country: United States