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NCT01111682 · ClinicalTrials.gov registry record · Phase 3
Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure
A Phase 3 study, sponsored by University of Cincinnati.
- Terminated
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
NCT01111682: Clinical Trial Phase 3 study, sponsored by University of Cincinnati.
NCT01111682 is a Phase 3 study that was terminated before completion, run by University of Cincinnati. The registered enrollment target is 5 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01111682, a Phase 3 study, was terminated before completion, sponsored by University of Cincinnati.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study examines the role of osmotic agents in controlling brain swelling in brain injured individuals. Two osmotic agents -- mannitol and hypertonic saline -- are in common use, and they will be compared in the context of a randomized clinical trial. The goal is to determine if these agent differ in their ability to control episodes of brain swelling.
Primary Outcome
ICP will be recorded continuously and the proportion of time during which ICP is uncontrolled will be calculated. Specifically, this will be measured as any period during which ICP \> 20 mmHg for 600 seconds or longer.
Interventions
- DRUG Mannitol
- DRUG Hypertonic Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-04 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
Why NCT01111682 stopped before completion
NCT01111682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Mannitol is the first listed.
NCT01111682 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01111682 about?
NCT01111682 is a clinical study titled "Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure". This study examines the role of osmotic agents in controlling brain swelling in brain injured individuals. Two osmotic agents -- mannitol and hypertonic saline -- are in common use, and they will be compared in the context of a randomized clinical trial. The goal is to determine if these agent diffe...
What is the current status of trial NCT01111682?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2010-04. Estimated completion is 2010-11.
What interventions are being tested in trial NCT01111682?
The interventions under investigation include: Mannitol (DRUG), Hypertonic Saline (DRUG).
Who is sponsoring clinical trial NCT01111682?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01111682's enrollment target sits among peer trials
5 1997th of 2000 higher than 3 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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