Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

Conditions
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Ischemia, Vasopressor

Intervention / Treatment
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* Drug: Injection of botulinum toxin A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox injection<br>Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia | Drug: Injection of botulinum toxin A<br>* One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy<br>* Other names: Botox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vasopressor, Digital ischemia