Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
Status:
Terminated
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Duke University
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA Vasoconstrictor Agents