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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 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 2 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01483209
The ClinicalTrials.gov registry entry for NCT01483209 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Injection of botulinum toxin A is the first listed.
NCT01483209 reports 0 study locations.
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.
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