Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

February 16, 2015 updated by: Duke University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perfusion (as Determined by Laser Doppler Measurements)
Time Frame: 12 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digital Amputations
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Cynthia Shortell, MD, Duke UMC
  • Study Director: Detlev Erdmann, M.D., Ph. D., Duke UMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

November 30, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Estimate)

March 2, 2015

Last Update Submitted That Met QC Criteria

February 16, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00032002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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