Acute Lung Injury
Conditions
Keywords
nutrition, enteral feeding, parenteral feeding, hospital malnutrition
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.
Interventions
BEHAVIORALintensive medical nutrition
provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge
OTHERcontrol
participants will receive standard care for nutrition received from hospital admission to discharge
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immune Parameters | baseline and weekly while hospitalized | Markers of immune response (including IL-6, IL-10, adiponectin, leptin, CRP, TNF, CD4/CD8 and HLA/CD14 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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 | 38 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 16 | 6 |
Baseline characteristics
| Characteristic | Intensive Medical Nutrition | Control | Total |
|---|---|---|---|
| Acute Physiology and Chronic Health Evaluation II (APACHE II) | 23.4 units on a scale STANDARD_DEVIATION 9.3 | 27.7 units on a scale STANDARD_DEVIATION 7.9 | 25.5 units on a scale STANDARD_DEVIATION 8.9 |
| Age, Continuous age | 52.5 years STANDARD_DEVIATION 17.1 | 58.6 years STANDARD_DEVIATION 16.2 | 55.4 years STANDARD_DEVIATION 16.7 |
| body mass index | 29.8 Kg/m2 STANDARD_DEVIATION 9.3 | 30.1 Kg/m2 STANDARD_DEVIATION 8.9 | 30 Kg/m2 STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 11 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 27 Participants | 57 Participants |
| Region of Enrollment United States | 40 participants | 38 participants | 78 participants |
| Sequential Organ Functional Assessment (SOFA) | 9.3 units on a scale STANDARD_DEVIATION 3.8 | 9.4 units on a scale STANDARD_DEVIATION 3.4 | 9.3 units on a scale STANDARD_DEVIATION 3.6 |
| Sex: Female, Male Female | 21 Participants | 17 Participants | 38 Participants |
| Sex: Female, Male Male | 19 Participants | 21 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 38 |
| serious Total, serious adverse events | 16 / 40 | 6 / 38 |
Outcome results
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
Time frame: Assessed daily from study enrollment through hospital discharge, an average of 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Medical Nutrition | Infection | 5 participants |
| Control | Infection | 8 participants |
p-value: 0.29Chi-squared
Secondary
Days on Mechanical Ventilation
the total number of days requiring mechanical ventilation while hospitalized
Time frame: days
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Medical Nutrition | Death | 16 participants |
| Control | Death | 6 participants |
Secondary
Length of Hospital Stay
The total number of days the patient is in the hospital
Time frame: days in hospital
Other Pre-specified
Immune Parameters
Markers of immune response (including IL-6, IL-10, adiponectin, leptin, CRP, TNF, CD4/CD8 and HLA/CD14
Time frame: baseline and weekly while hospitalized