Status:
TERMINATED
Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
Lead Sponsor:
Duke University
Conditions:
Ischemia
Vasopressor
Eligibility:
All Genders
18+ years
Phase:
NA
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 prospe...
Eligibility Criteria
Inclusion
- Be admitted to the ICU
- Have digital ischemia and
- Be on a vasopressor infusion
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01483209
Start Date
March 1 2012
End Date
April 1 2014
Last Update
March 2 2015
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710