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

N/ATerminatedNCT01921101

University of Illinois at Chicago78 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Lung Injury

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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. -

Outcomes

Primary Outcomes

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

Time frame: Assessed daily from study enrollment through hospital discharge, an average of 3 weeks

Secondary Outcomes

Length of Hospital Stay

The total number of days the patient is in the hospital

Time frame: days in hospital

Days on Mechanical Ventilation

the total number of days requiring mechanical ventilation while hospitalized

Time frame: days

Death

The date of death for all participants that die between enrollment and their final data collection, 24 weeks following hospital discharge

Time frame: date of occurence