NCT01921101

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 14, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

3.9 years

First QC Date

July 3, 2013

Results QC Date

April 15, 2014

Last Update Submit

August 1, 2014

Conditions

Acute Lung Injury

Keywords

nutritionenteral feedingparenteral feedinghospital malnutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Length of Hospital Stay

    days in hospital

  • Days on Mechanical Ventilation

    days

  • Death

    date of occurence

Other Outcomes (1)

  • Immune Parameters

    baseline and weekly while hospitalized

Study Arms (2)

intensive medical nutrition

OTHER

participants will receive intensive medical nutrition from hospital admission to discharge

Behavioral: intensive medical nutrition

control

OTHER

participants will not receive intensive nutritional support from hospital admission to discharge

Other: control

Interventions

intensive medical nutritionBEHAVIORAL

provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge

intensive medical nutrition
controlOTHER

participants will receive standard care for nutrition received from hospital admission to discharge

control

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (8)

  • Sheean PM, Peterson SJ, Chen Y, Liu D, Lateef O, Braunschweig CA. Utilizing multiple methods to classify malnutrition among elderly patients admitted to the medical and surgical intensive care units (ICU). Clin Nutr. 2013 Oct;32(5):752-7. doi: 10.1016/j.clnu.2012.12.012. Epub 2013 Jan 5.

    PMID: 23340043BACKGROUND

  • Sheean PM, Peterson SJ, Zhao W, Gurka DP, Braunschweig CA. Intensive medical nutrition therapy: methods to improve nutrition provision in the critical care setting. J Acad Nutr Diet. 2012 Jul;112(7):1073-9. doi: 10.1016/j.jand.2012.02.007. Epub 2012 May 12.

    PMID: 22579721BACKGROUND

  • Peterson SJ, Sheean PM, Braunschweig CL. Orally fed patients are at high risk of calorie and protein deficit in the ICU. Curr Opin Clin Nutr Metab Care. 2011 Mar;14(2):182-5. doi: 10.1097/MCO.0b013e3283428e65.

    PMID: 21178611BACKGROUND

  • Braunschweig CA, Sheean PM, Peterson SJ. Examining the role of nutrition support and outcomes for hospitalized patients: putting nutrition back in the study design. J Am Diet Assoc. 2010 Nov;110(11):1646-9. doi: 10.1016/j.jada.2010.08.019.

    PMID: 21034876BACKGROUND

  • Sheean PM, Peterson SJ, Gurka DP, Braunschweig CA. Nutrition assessment: the reproducibility of subjective global assessment in patients requiring mechanical ventilation. Eur J Clin Nutr. 2010 Nov;64(11):1358-64. doi: 10.1038/ejcn.2010.154. Epub 2010 Aug 11.

    PMID: 20700137BACKGROUND

  • Peterson SJ, Tsai AA, Scala CM, Sowa DC, Sheean PM, Braunschweig CL. Adequacy of oral intake in critically ill patients 1 week after extubation. J Am Diet Assoc. 2010 Mar;110(3):427-33. doi: 10.1016/j.jada.2009.11.020.

    PMID: 20184993BACKGROUND

  • Braunschweig CA, Sheean PM, Peterson SJ, Gomez Perez S, Freels S, Lateef O, Gurka D, Fantuzzi G. Intensive nutrition in acute lung injury: a clinical trial (INTACT). JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):13-20. doi: 10.1177/0148607114528541. Epub 2014 Apr 9.

    PMID: 24722769RESULT

  • Braunschweig CL, Freels S, Sheean PM, Peterson SJ, Perez SG, McKeever L, Lateef O, Gurka D, Fantuzzi G. Role of timing and dose of energy received in patients with acute lung injury on mortality in the Intensive Nutrition in Acute Lung Injury Trial (INTACT): a post hoc analysis. Am J Clin Nutr. 2017 Feb;105(2):411-416. doi: 10.3945/ajcn.116.140764. Epub 2016 Dec 14.

    PMID: 27974311DERIVED

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Carol Braunschweig, Professor
Organization
University of Illinois at Chicago
braunsch@uic.edu
3129962575

Study Officials

  • carol l braunschweig, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2013

First Posted

August 13, 2013

Study Start

July 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 6, 2014

Results First Posted

May 14, 2014

Record last verified: 2014-08

Locations

US(1)