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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intensive Nutrition in ARDS: A Clinical Trail (INTACT)

Conditions
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Acute Lung Injury

Intervention / Treatment
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* Behavioral: intensive medical nutrition
* Other: control


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intensive medical nutrition<br>participants will receive intensive medical nutrition from hospital admission to discharge | Behavioral: intensive medical nutrition<br>* provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge<br>|
| Other: control<br>participants will not receive intensive nutritional support from hospital admission to discharge | Other: control<br>* participants will receive standard care for nutrition received from hospital admission to discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | 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 | Assessed daily from study enrollment through hospital discharge, an average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | The total number of days the patient is in the hospital | days in hospital | 
| Days on Mechanical Ventilation | the total number of days requiring mechanical ventilation while hospitalized | days | 
| Death | The date of death for all participants that die between enrollment and their final data collection, 24 weeks following hospital discharge | date of occurence | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, enteral feeding, parenteral feeding, hospital malnutrition