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

University of Illinois

Status: Terminated

Conditions: Acute Lung Injury

Treatments: Behavioral: intensive medical nutrition; Other: control

Study type: Interventional

Funder types: Other

Identifiers

NCT01921101

685

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Adult patients (> 18 years) with a diagnosis of acute lung injury, with viable GI function for enteral feeding

Exclusion Criteria: Patients who are (1) transferred from another ICU, (2) previously admitted to the ICU during the same hospitalization, (3) do not resuscitate status or < 12 month perceived survival due to underlying disease state (4) severely immunosuppressed, (5) immobility prior to ICU admission, (6) documented neurological disease prior to admission. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

intensive medical nutrition

Other group

Description:

participants will receive intensive medical nutrition from hospital admission to discharge

Treatment:

Behavioral: intensive medical nutrition

control

Other group

Description:

participants will not receive intensive nutritional support from hospital admission to discharge

Treatment:

Other: control