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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01921101
Recruitment Status : Terminated (greater mortality in intervention group)
First Posted : August 13, 2013
Results First Posted : May 14, 2014
Last Update Posted : August 6, 2014
Information provided by (Responsible Party):
Carol Braunschweig, University of Illinois at Chicago

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Lung Injury Behavioral: intensive medical nutrition Other: control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensive Nutrition in ARDS: A Clinical Trail (INTACT)
Study Start Date : July 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
intensive medical nutrition
participants will receive intensive medical nutrition from hospital admission to discharge
Behavioral: intensive medical nutrition
provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge

participants will not receive intensive nutritional support from hospital admission to discharge
Other: control
participants will receive standard care for nutrition received from hospital admission to discharge

Primary Outcome Measures :
  1. Infection [ Time Frame: Assessed daily from study enrollment through hospital discharge, an average of 3 weeks ]
    All new infections that occurred (including blood, wound, sputum, urinary tract and pulmonary) from enrollment through hospital discharge recorded in the medical record were counted

Secondary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: days in hospital ]
    The total number of days the patient is in the hospital

  2. Days on Mechanical Ventilation [ Time Frame: days ]
    the total number of days requiring mechanical ventilation while hospitalized

  3. Death [ Time Frame: date of occurence ]
    The date of death for all participants that die between enrollment and their final data collection, 24 weeks following hospital discharge

Other Outcome Measures:
  1. Immune Parameters [ Time Frame: baseline and weekly while hospitalized ]
    Markers of immune response (including IL-6, IL-10, adiponectin, leptin, CRP, TNF, CD4/CD8 and HLA/CD14

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01921101

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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
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Principal Investigator: carol l braunschweig, PhD University of Illinois at Chicago
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Carol Braunschweig, Professor, University of Illinois at Chicago Identifier: NCT01921101    
Obsolete Identifiers: NCT01071330
Other Study ID Numbers: 685
First Posted: August 13, 2013    Key Record Dates
Results First Posted: May 14, 2014
Last Update Posted: August 6, 2014
Last Verified: August 2014
Keywords provided by Carol Braunschweig, University of Illinois at Chicago:
enteral feeding
parenteral feeding
hospital malnutrition
Additional relevant MeSH terms:
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Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders