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NCT01483209 · ClinicalTrials.gov registry record · NA
Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
A NA study, sponsored by Duke University.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT01483209: Clinical Trial NA study, sponsored by Duke University.
NCT01483209 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01483209, a NA study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
The goal of this project is to determine if performing a "chemical sympathectomy" by injecting botulinum toxin A in critically ill patients on vasopressors can treat digital ischemia. This is a prospective, non-randomized pilot study designed to demonstrate proof of concept. We propose to study patients in the intensive care units of Duke Hospital who, secondary to exposure to vasoactive medications used to maintain acceptable blood pressures, have developed signs and symptoms of digital ischemia. A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. There were no major adverse events reported by the product information sheet or in other related studies of Botox for digital ischemia.
Primary Outcome
A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. Results for the experimental and control groups will be plotted and displayed graphically as percent change in Doppler flow (y-axis) and time (x-axis).
Interventions
- DRUG Injection of botulinum toxin A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-04 |
| Phase | NA |
Why NCT01483209 stopped before completion
NCT01483209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Injection of botulinum toxin A is the first listed.
NCT01483209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01483209 about?
NCT01483209 is a clinical study titled "Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A". The goal of this project is to determine if performing a "chemical sympathectomy" by injecting botulinum toxin A in critically ill patients on vasopressors can treat digital ischemia. This is a prospective, non-randomized pilot study designed to demonstrate proof of concept. We propose to study pati...
What is the current status of trial NCT01483209?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2012-03. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01483209?
The interventions under investigation include: Injection of botulinum toxin A (DRUG).
Who is sponsoring clinical trial NCT01483209?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01483209's enrollment target sits among peer trials
2 1997th of 2000 the lowest 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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