Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

NCT ID: NCT01483209

Last Updated: 2015-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-04-30

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.

Conditions

Ischemia; Vasopressor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botox injection

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

Group Type: EXPERIMENTAL

Injection of botulinum toxin A

Intervention Type: DRUG

One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy

Interventions

Injection of botulinum toxin A

One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy

Intervention Type: DRUG

Other Intervention Names

Botox

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia Shortell, MD

Role: PRINCIPAL_INVESTIGATOR

Duke UMC

Detlev Erdmann, M.D., Ph. D.

Role: STUDY_DIRECTOR

Duke UMC

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00032002

Identifier Type: -

Identifier Source: org_study_id