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

Acute Lung Injury Clinical Trial

— INTACT  

Official title:

Intensive Nutrition in ARDS: A Clinical Trail (INTACT)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01921101
• Other study ID #: 685
• Status: Terminated
• Phase: N/A
• First received: July 3, 2013
• Last updated: August 1, 2014
• Start date: July 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2014
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01071330

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Behavioral:
• intensive medical nutrition
provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge

Other:
• control
participants will receive standard care for nutrition received from hospital admission to discharge

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (7)

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 2 — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immune Parameters	Markers of immune response (including IL-6, IL-10, adiponectin, leptin, CRP, TNF, CD4/CD8 and HLA/CD14	baseline and weekly while hospitalized	Yes
Primary	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	Yes
Secondary	Length of Hospital Stay	The total number of days the patient is in the hospital	days in hospital	Yes
Secondary	Days on Mechanical Ventilation	the total number of days requiring mechanical ventilation while hospitalized	days	Yes
Secondary	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	Yes