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NCT01921101 · ClinicalTrials.gov registry record · NA
Intensive Nutrition in Acute Respiratory Distress Syndrome (ARDS): A Clinical Trial (INTACT)
A NA study, sponsored by University of Illinois at Chicago.
- Terminated
- Registry status
- NA
- Development phase
- 78
- Enrollment target
NCT01921101 is a NA study that was terminated before completion, run by University of Illinois at Chicago. The registered enrollment target is 78 participants.
The verdict
NCT01921101, a NA study, was terminated before completion, sponsored by University of Illinois at Chicago.
- TERMINATED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
Study 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.
Interventions
- OTHER control
- BEHAVIORAL intensive medical nutrition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2009-07 |
| Est. Completion | 2013-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01921101
The ClinicalTrials.gov registry entry for NCT01921101 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which control is the first listed.
NCT01921101 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01921101 about?
NCT01921101 is a clinical study titled "Intensive Nutrition in Acute Respiratory Distress Syndrome (ARDS): A Clinical Trial (INTACT)". 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...
What is the current status of trial NCT01921101?
This trial is currently terminated. It is a NA study. The enrollment target is 78 participants. The study started on 2009-07. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01921101?
The interventions under investigation include: control (OTHER), intensive medical nutrition (BEHAVIORAL).
Who is sponsoring clinical trial NCT01921101?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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