Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

Duke University2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemia Vasopressor

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be admitted to the ICU * Have digital ischemia and * Be on a vasopressor infusion Exclusion Criteria: * Patients with a history of systemic sclerosis * Patients actively receiving aminoglycoside antibiotics - aminoglycosides may potentiate the effect of Botox * Patients who have previously received botulinum toxin (A or B) injections * Patients with a history of disorders of neuromuscular transmission (e.g myasthenia gravis, Lambert-Eaton, etc.) - Botox may have a lasting effect in these patients given their disorder * Patients with clinical evidence of an infection in either forearm or hand * Patients with a history of sensitivity to albumin - Botox is sold in powder form and there is albumin in the formulation * Pregnancy - Botox is a class C medication * Rheumatoid Arthritis * Upper extremity arterio-venous graft or fistula * Digital necrosis * History of hand amputation * Patients whom the intensive care attending physician deems will expire within 48 hours

Outcomes

Primary Outcomes

Perfusion (as Determined by Laser Doppler Measurements)

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).

Time frame: 12 months

Secondary Outcomes

Digital Amputations

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.