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Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

Primary Purpose

Ischemia, Vasopressor

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Injection of botulinum toxin A
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia focused on measuring Digital ischemia, Vasopressor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Botox injection

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
November 29, 2011
Last Updated
February 16, 2015
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT01483209
Brief Title
Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
Official Title
Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Vasopressor
Keywords
Digital ischemia, Vasopressor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox injection
Arm Type
Experimental
Arm Description
Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia
Intervention Type
Drug
Intervention Name(s)
Injection of botulinum toxin A
Other Intervention Name(s)
Botox
Intervention Description
One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy
Primary Outcome Measure Information:
Title
Perfusion (as Determined by Laser Doppler Measurements)
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Digital Amputations
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Shortell, MD
Organizational Affiliation
Duke UMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Detlev Erdmann, M.D., Ph. D.
Organizational Affiliation
Duke UMC
Official's Role
Study Director
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

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