drugset / Trial / NCT01483209

Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

NCT01483209

Terminated 2 enrolled Duke University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-03
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 100 iu

Indications