NCT01483209

Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemia
• Vasopressor

Interventions

Type	Name	Description
DRUG	Injection of botulinum toxin A	One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2011-12-01
• Last updated: 2015-03-02
• Results posted: 2015-03-02

Locations

1 site across 1 country: United States