Intensive Nutrition in ARDS: A Clinical Trial (INTACT)
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 5/5/2014 |
| Start Date: | July 2009 |
| End Date: | June 2014 |
Intensive Nutrition in ARDS: A Clinical Trail (INTACT)
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.
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.
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.
-
We found this trial at
1
site
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
Click here to add this to my saved trials
