Intensive Nutrition in ARDS: A Clinical Trial (INTACT)
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Purpose
We 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 | Phase |
|---|---|---|
|
Acute Respiratory Distress Syndrome |
Other: intensive medical nutrition therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of Medical Nutritional Therapy vs. Standard Care in Patients With Acute Respiratory Distress Syndrome |
- incidence of infection [ Time Frame: hospitalizatioin ] [ Designated as safety issue: No ]
- require fewer days of mechanical ventilation [ Time Frame: hospitalization ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: intensive medical nutrition therapy
intensive medical nutrition therapy is early enteral nutrition + intensive diet therapy when oral intake is initiated to meet the patients energy and protein needs from hospital admission to discharge. Standard care is that nutritional care provided by routine medical care.
|
Other: intensive medical nutrition therapy
Intensive medical nutritional therapy provides patients with early enteral nutrition + intensive diet therapy when oral intake is initiated to meet energy and protein needs from hospital admission to discharge
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: adult patients with acute lung injury or acute respiratory distress syndrome
-
Exclusion Criteria:
- HIV, DNR, active cancer
Contacts and Locations More Information
No publications provided
| Responsible Party: | Carol Braunschweig Associate Professor, University of Illinois at Chicago |
| ClinicalTrials.gov Identifier: | NCT01071330 History of Changes |
| Other Study ID Numbers: | 685, 5R01HL093142-02 |
| Study First Received: | February 17, 2010 |
| Last Updated: | April 16, 2010 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |
ClinicalTrials.gov processed this record on May 16, 2013