Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

Duke University

Status: Terminated

Conditions: Ischemia; Vasopressor

Treatments: Drug: Injection of botulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT01483209

Pro00032002

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Botox injection

Experimental group

Description:

Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia

Treatment:

Drug: Injection of botulinum toxin A