Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

Ischemia Clinical Trial

Official title:

Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01483209
• Other study ID #: Pro00032002
• Status: Terminated
• Phase: N/A
• First received: November 29, 2011
• Last updated: February 16, 2015
• Start date: March 2012
• Est. completion date: April 2014

Study information

• Verified date: February 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Vasopressor

Intervention

Drug:
• Injection of botulinum toxin A
One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No