Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | March 2012 |
| End Date: | December 2013 |
| Contact: | Detlev Erdmann, M.D., Ph. D. |
| Email: | detlev.erdmann@duke.edu |
| Phone: | 919-684-3320 |
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.
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.
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
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