Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00796419 · ClinicalTrials.gov registry record · Phase 3
Comparative Evaluation of Albumin and Starch Effects in Acute Lung Injury (ALI)
A Phase 3 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
NCT00796419 is a Phase 3 study that was terminated before completion, run by Emory University. The registered enrollment target is 31 participants.
The verdict
NCT00796419, a Phase 3 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
Study Summary
Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are similar conditions in which the lungs are critically injured by another inflammatory process in the body. Together they affect more than 150,000 people per year in the United States, with mortality approaching 50% and a financial burden estimated to exceed $5 billion. Fluid overload, weight gain, and reduced oncotic pressure (low blood proteins) are associated with prolonged need for mechanical ventilation and mortality in patients with ALI/ARDS. Historical studies have provided conflicting evidence for benefits with colloid or diuretic therapy in ALI/ARDS, but recent clinical trials have demonstrated significant improvements in blood oxygen levels. The mechanisms of these benefits are not yet certain, but appear to relate to albumin's (a protein medicine) specific ability to influence injury and inflammation in the lungs, thus improving the ability for the lung to repair and exchange oxygen. The purpose of this project is to determine the effects of therapies that affect blood proteins on their ability to change the way the lungs and cardiovascular system (heart and blood vessels) function. Special measurements will be taken to understand how these protein medicines change the ability of the lung and whole body to recover from widespread injury, with additional measures of specific heart and lung function. This clinical trial randomizes ALI/ARDS patients with low blood protein levels to receive albumin (a natural blood protein that is known to influence inflammation) or hetastarch (a synthetic blood protein) with diuretic therapy targeted to improve respiratory function. Therapeutic effects on respiratory function and blood oxygen levels, extravascular lung water, oncotic pressure, lung fluid removal, and heart function will be characterized. This trial will advance our understanding of treatment of ALI/ARDS and the factors that affect fluid balance in the lungs of these patients. Funding
Interventions
- DRUG 5% human albumin
- DRUG 6% hetastarch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2009-01 |
| Est. Completion | 2016-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00796419
The ClinicalTrials.gov registry entry for NCT00796419 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 5% human albumin is the first listed.
NCT00796419 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00796419 about?
NCT00796419 is a clinical study titled "Comparative Evaluation of Albumin and Starch Effects in Acute Lung Injury (ALI)". Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are similar conditions in which the lungs are critically injured by another inflammatory process in the body. Together they affect more than 150,000 people per year in the United States, with mortality approaching 50% and a finan...
What is the current status of trial NCT00796419?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2009-01. Estimated completion is 2016-11.
What interventions are being tested in trial NCT00796419?
The interventions under investigation include: 5% human albumin (DRUG), 6% hetastarch (DRUG).
Who is sponsoring clinical trial NCT00796419?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.