Trial Outcomes & Findings for Intensive Nutrition in Acute Respiratory Distress Syndrome (ARDS): A Clinical Trial (INTACT) (NCT NCT01921101)
NCT ID: NCT01921101
Last Updated: 2014-08-06
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
Assessed daily from study enrollment through hospital discharge, an average of 3 weeks
Results posted on
2014-08-06
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
38
|
|
Overall Study
COMPLETED
|
24
|
32
|
|
Overall Study
NOT COMPLETED
|
16
|
6
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Death
|
16
|
6
|
Baseline Characteristics
Intensive Nutrition in Acute Respiratory Distress Syndrome (ARDS): A Clinical Trial (INTACT)
Baseline characteristics by cohort
| Measure |
Intensive Medical Nutrition
n=40 Participants
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
|
Control
n=38 Participants
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
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
age
|
52.5 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 16.2 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
38 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Acute Physiology and Chronic Health Evaluation II (APACHE II)
|
23.4 units on a scale
STANDARD_DEVIATION 9.3 • n=5 Participants
|
27.7 units on a scale
STANDARD_DEVIATION 7.9 • n=7 Participants
|
25.5 units on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sequential Organ Functional Assessment (SOFA)
|
9.3 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
9.4 units on a scale
STANDARD_DEVIATION 3.4 • n=7 Participants
|
9.3 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
body mass index
|
29.8 Kg/m2
STANDARD_DEVIATION 9.3 • n=5 Participants
|
30.1 Kg/m2
STANDARD_DEVIATION 8.9 • n=7 Participants
|
30 Kg/m2
STANDARD_DEVIATION 9.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed daily from study enrollment through hospital discharge, an average of 3 weeksAll new infections that occurred (including blood, wound, sputum, urinary tract and pulmonary) from enrollment through hospital discharge recorded in the medical record were counted
Outcome measures
| Measure |
Intensive Medical Nutrition
n=40 Participants
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
|
Control
n=38 Participants
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
|
|---|---|---|
|
Infection
|
5 participants
|
8 participants
|
SECONDARY outcome
Timeframe: days in hospitalThe total number of days the patient is in the hospital
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: daysthe total number of days requiring mechanical ventilation while hospitalized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: date of occurenceThe date of death for all participants that die between enrollment and their final data collection, 24 weeks following hospital discharge
Outcome measures
| Measure |
Intensive Medical Nutrition
n=40 Participants
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
|
Control
n=38 Participants
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
|
|---|---|---|
|
Death
|
16 participants
|
6 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and weekly while hospitalizedMarkers of immune response (including IL-6, IL-10, adiponectin, leptin, CRP, TNF, CD4/CD8 and HLA/CD14
Outcome measures
Outcome data not reported
Adverse Events
Intensive Medical Nutrition
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intensive Medical Nutrition
n=40 participants at risk
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
|
Control
n=38 participants at risk
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
|
|---|---|---|
|
General disorders
death
|
40.0%
16/40 • Number of events 16 • From enrollment throughout hospitalization in all participants, an average of 3 weeks
hyperglycemia, hypoglycemia, aspiration, tube feeding complications, parenteral nutrition complications, death
|
15.8%
6/38 • Number of events 6 • From enrollment throughout hospitalization in all participants, an average of 3 weeks
hyperglycemia, hypoglycemia, aspiration, tube feeding complications, parenteral nutrition complications, death
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carol Braunschweig, Professor
University of Illinois at Chicago
Phone: 3129962575
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place