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 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A|
- Perfusion (as determined by Laser Doppler measurements) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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).
- Digital amputations [ Time Frame: 12 months ] [ Designated as safety issue: No ]The number of digits amputated in our patient cohort is a secondary endpoint of this study. We will use a paired t-test to compare the number of digital amputations in the control versus experimental group.
|Study Start Date:||March 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Botox injection
Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia
Drug: Injection of botulinum toxin A
One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy
Other Name: Botox
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483209
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Cynthia Shortell, MD||Duke UMC|
|Study Director:||Detlev Erdmann, M.D., Ph. D.||Duke UMC|