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
  Purpose

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.


Condition Intervention
Ischemia
Vasopressor
Drug: Injection of botulinum toxin A

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 2
Study Start Date: March 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botox injection
Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483209

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Cynthia Shortell, MD Duke UMC
Study Director: Detlev Erdmann, M.D., Ph. D. Duke UMC
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01483209     History of Changes
Other Study ID Numbers: Pro00032002
Study First Received: November 29, 2011
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Digital ischemia
Vasopressor

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Botulinum Toxins, Type A
Botulinum Toxins
Vasoconstrictor Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014