Trial record 6 of 80 for:    Open Studies | "Thoracic Injuries"

Intensive Nutrition in ARDS: A Clinical Trial (INTACT)

This study is currently recruiting participants.
Verified August 2013 by University of Illinois at Chicago
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 12, 2013
Last verified: August 2013
  Purpose

The investigators propose a prospective randomized clinical trail to evaluate the impact of intensive medical nutrition therapy (IMNT) in malnourished patients with ARDS 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 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,l 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: during hospitalization ] [ Designated as safety issue: Yes ]
    All infections that occur (including blood, wound, sputum, urinary tract and pulmonary) following recruitment recorded in the medical record will be included.


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 occurance ] [ Designated as safety issue: Yes ]
    The date of death for all participants that die between enrollment and their final data colleciton (6-months after 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


Estimated Enrollment: 200
Study Start Date: July 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (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 nutriitonal support from hosptial admission to discharge
Other: control
participants will receive standard care for nutrition received from hosptial admission to discharge

  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 ARDS, classified as moderate or severely malnourished by SGA, 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 recesitate status or < 12 month perceived survival due to underlying disease state (4) severely immunosupressed, (5) immobility prior to ICU admission, (6) documented neurologic disease prior to admission. -

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

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: carol braunschweig, phD    312-996-2575    braunsch@uic.edu   
Contact: sandra gomez, ms    312-413-9896    slgomez@uic.edu   
Principal Investigator: david gurka, MD, PhD         
Sponsors and Collaborators
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
Last Updated: August 12, 2013
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:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries

ClinicalTrials.gov processed this record on April 22, 2014