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NCT01667666 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial of Nebulized Hypertonic Saline to Attenuate Post-Traumatic Acute Lung Injury
A Phase 1 study, sponsored by Denver Health and Hospital Authority.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01667666: Clinical Trial Phase 1 study, sponsored by Denver Health and Hospital Authority.
NCT01667666 is a Phase 1 study that was terminated before completion, run by Denver Health and Hospital Authority. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01667666, a Phase 1 study, was terminated before completion, sponsored by Denver Health and Hospital Authority.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This study evaluates the use of nebulized hypertonic saline (aerosolized salt water) as a preventive treatment for post-traumatic acute lung injury (ALI). Both animal and human research indicate that aerosolized salt water might help reduce harmful inflammation with minimal risks.
Primary Outcome
For intubated patients - A decrease greater than 20% in PaO2/FiO2 (P/F) ratios will trigger DSMB review. For not intubated patients - a) the need to increase FiO2 by 10% (approximate 4 liter/minute increase) to maintain a peripheral oxygen saturation (SaO2) of 90% during nebulizer treatment; b) evidence of respiratory distress (as documented in the chart by the patient's attending) during nebulizer treatment; and c) respiratory insufficiency requiring intubation and mechanical ventilation at any
Interventions
- DRUG Nebulized hypertonic saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2012-05 |
| Est. Completion | 2018-11-06 |
| Phase | Phase 1 |
Why NCT01667666 stopped before completion
NCT01667666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Nebulized hypertonic saline is the first listed.
NCT01667666 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01667666 about?
NCT01667666 is a clinical study titled "Clinical Trial of Nebulized Hypertonic Saline to Attenuate Post-Traumatic Acute Lung Injury". This study evaluates the use of nebulized hypertonic saline (aerosolized salt water) as a preventive treatment for post-traumatic acute lung injury (ALI). Both animal and human research indicate that aerosolized salt water might help reduce harmful inflammation with minimal risks.
What is the current status of trial NCT01667666?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2012-05. Estimated completion is 2018-11-06.
What interventions are being tested in trial NCT01667666?
The interventions under investigation include: Nebulized hypertonic saline (DRUG).
Who is sponsoring clinical trial NCT01667666?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01667666's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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