Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01483209
First received: November 29, 2011
Last updated: April 14, 2014
Last verified: April 2014

November 29, 2011
April 14, 2014
March 2012
April 2014   (final data collection date for primary outcome measure)
Perfusion (as determined by Laser Doppler measurements) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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).
Same as current
Complete list of historical versions of study NCT01483209 on ClinicalTrials.gov Archive Site
Digital amputations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ischemia
  • Vasopressor
Drug: Injection of botulinum toxin A
One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy
Other Name: Botox
Experimental: Botox injection
Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia
Intervention: Drug: Injection of botulinum toxin A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01483209
Pro00032002
Yes
Duke University
Duke University
Not Provided
Principal Investigator: Cynthia Shortell, MD Duke UMC
Study Director: Detlev Erdmann, M.D., Ph. D. Duke UMC
Duke University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP