NCT01483209

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 2, 2015

Completed
Last Updated

March 2, 2015

Status Verified

February 1, 2015

Enrollment Period

2.1 years

First QC Date

November 29, 2011

Results QC Date

February 16, 2015

Last Update Submit

February 16, 2015

Conditions

IschemiaVasopressor

Keywords

Digital ischemiaVasopressor

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Digital Amputations

    12 months

Study Arms (1)

Botox injection

EXPERIMENTAL

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

Drug: Injection of botulinum toxin A

Interventions

Injection of botulinum toxin ADRUG

One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy

Also known as: Botox
Botox injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be admitted to the ICU
  • Have digital ischemia and
  • Be on a vasopressor infusion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Ischemia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Limitations and Caveats

Due to low accrual for this study we were unable to perform any data analysis.

Results Point of Contact

Title
Dr. Cynthia Shortell
Organization
Duke University Medical Center
cynthia.shortell@duke.edu
919-681-2223

Study Officials

  • Cynthia Shortell, MD

    Duke UMC

    PRINCIPAL INVESTIGATOR

  • Detlev Erdmann, M.D., Ph. D.

    Duke UMC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

March 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 2, 2015

Results First Posted

March 2, 2015

Record last verified: 2015-02

Locations

US(1)