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

This study has been terminated.
(greater mortality in intervention group)
Sponsor:
Information provided by (Responsible Party):
Carol Braunschweig, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01921101
First received: July 3, 2013
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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 Intervention
Acute Lung Injury
Behavioral: intensive medical nutrition
Other: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensive Nutrition in ARDS: A Clinical Trail (INTACT)

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Infection [ Time Frame: Assessed daily from study enrollment through hospital discharge, an average of 3 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Length of Hospital Stay [ Time Frame: days in hospital ] [ Designated as safety issue: Yes ]
    The total number of days the patient is in the hospital

  • Days on Mechanical Ventilation [ Time Frame: days ] [ Designated as safety issue: Yes ]
    the total number of days requiring mechanical ventilation while hospitalized

  • Death [ Time Frame: date of occurence ] [ Designated as safety issue: Yes ]
    The date of death for all participants that die between enrollment and their final data collection, 24 weeks following hospital discharge


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


Enrollment: 78
Study Start Date: July 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
control
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01921101

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: carol l braunschweig, PhD University of Illinois at Chicago
  More Information

Publications:

Responsible Party: Carol Braunschweig, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01921101     History of Changes
Obsolete Identifiers: NCT01071330
Other Study ID Numbers: 685
Study First Received: July 3, 2013
Results First Received: April 15, 2014
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
nutrition
enteral feeding
parenteral feeding
hospital malnutrition

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Injury
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014