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

Not Applicable

Terminated

• Conditions: Acute Lung Injury
• Interventions: Other: control; Behavioral: intensive medical nutrition

• Registration Number: NCT01921101
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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

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 Timeline

• Study Start: 2009-07
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-13
• Results First Submitted: 2014-04-15
• Results First Submitted QC: 2014-04-15
• Results First Posted: 2014-05-14
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-01
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	participants will not receive intensive nutritional support from hospital admission to discharge
intensive medical nutrition	intensive medical nutrition	participants will receive intensive medical nutrition from hospital admission to discharge

Primary Outcome Measures

Name	Time	Method
Infection	Assessed daily from study enrollment through hospital discharge, an average of 3 weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States