Not provided
Not provided
Not provided
greater mortality in intervention group
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intensive medical nutrition | Other | participants will receive intensive medical nutrition from hospital admission to discharge |
|
| control | Other | participants will not receive intensive nutritional support from hospital admission to discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive medical nutrition | Behavioral | provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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. -
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| carol l braunschweig, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23340043 | Background | 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. | |
| 22579721 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Medical Nutrition | participants will receive intensive medical nutrition from hospital admission to discharge intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge |
| FG001 | Control | participants will not receive intensive nutritional support from hospital admission to discharge control: participants will receive standard care for nutrition received from hospital admission to discharge |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
gender, race/ethnicity, age, diagnosis, admission height and weight, body mass index, ICU admission Acute Physiology and Chronic Health Evaluation II score, Sequential Organ Failure Assessment scores
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Medical Nutrition | participants will receive intensive medical nutrition from hospital admission to discharge intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | Assessed daily from study enrollment through hospital discharge, an average of 3 weeks |
|
From enrollment throughout hospitalization in all participants, an average of 3 weeks
hyperglycemia, hypoglycemia, aspiration, tube feeding complications, parenteral nutrition complications, death
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intensive Medical Nutrition | participants will receive intensive medical nutrition from hospital admission to discharge intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Systematic Assessment | death from enrollment to 24 weeks post hospital discharge |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carol Braunschweig, Professor | University of Illinois at Chicago | 3129962575 | braunsch@uic.edu |
Not provided
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| control | Other | participants will receive standard care for nutrition received from hospital admission to discharge |
|
| 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 |
| 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. |
| 21178611 | Background | 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. |
| 21034876 | Background | 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. |
| 20700137 | Background | 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. |
| 20184993 | Background | 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. |
| 24722769 | Result | 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. |
| 27974311 | Derived | 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. |
participants will not receive intensive nutritional support from hospital admission to discharge control: participants will receive standard care for nutrition received from hospital admission to discharge |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Acute Physiology and Chronic Health Evaluation II (APACHE II) | The Acute Physiology and Chronic Health Evaluation II (APACHE II) is a severity-of-disease classification. It is applied within 24 hours of admission to the intensive care unit. The scores range from 0-71; higher scores correspond to more severe disease and a higher risk of death | Mean | Standard Deviation | units on a scale |
|
| Sequential Organ Functional Assessment (SOFA) | The sequential organ failure assessment score (SOFA)is a scoring system used in critically ill patients to assess the extent of their organ function. The total score is based on six different scores, one of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. These scores range from 0-24; higher scores indicate more severe organ compromise. | Mean | Standard Deviation | units on a scale |
|
| body mass index | Body mass index was calculated based on admission weight (Kg)/ height (m)2; NIH classifications for BMI categories were used ( BMI < 18.5 malnourished; 18.5-24.9 normal weight, 25-29.9 overweight and > 30 obese) | Mean | Standard Deviation | Kg/m2 |
|
|
|
|
| Secondary | Length of Hospital Stay | The total number of days the patient is in the hospital | Not Posted | days in hospital |
| Secondary | Days on Mechanical Ventilation | the total number of days requiring mechanical ventilation while hospitalized | Not Posted | days |
| Secondary | Death | The date of death for all participants that die between enrollment and their final data collection, 24 weeks following hospital discharge | Posted | Number | participants | date of occurence |
|
|
|
| Other Pre-specified | Immune Parameters | Markers of immune response (including IL-6, IL-10, adiponectin, leptin, CRP, TNF, CD4/CD8 and HLA/CD14 | Not Posted | baseline and weekly while hospitalized |
| 16 |
| 40 |
| 0 |
| 40 |
| EG001 | Control | participants will not receive intensive nutritional support from hospital admission to discharge control: participants will receive standard care for nutrition received from hospital admission to discharge | 6 | 38 | 0 | 38 |
|
Not provided
Not provided