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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: Clinical Trial NA study, sponsored by University of Illinois at Chicago.
NCT01921101 is a NA study that was terminated before completion, run by University of Illinois at Chicago. The registered enrollment target is 78 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
Why NCT01921101 stopped before completion
NCT01921101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which control is the first listed.
NCT01921101 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01921101's enrollment target sits among peer trials
78 1060th of 2000 higher than 939 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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