Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

Not Applicable

Terminated

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Botox injection	Injection of botulinum toxin A	Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia

Primary Outcome Measures

Name	Time	Method
Perfusion (as Determined by Laser Doppler Measurements)	12 months	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).

Secondary Outcome Measures

Name	Time	Method
Digital Amputations	12 months	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.