Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
This study is currently recruiting participants.
Verified February 2013 by Duke University
Sponsor:
Duke University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01483209
First received: November 29, 2011
Last updated: February 4, 2013
Last verified: February 2013
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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:
MedlinePlus related topics:
Botox
Drug Information available for:
OnabotulinumtoxinA
U.S. FDA Resources
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.
| Estimated Enrollment: | 15 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483209
Contacts
| Contact: Detlev Erdmann, M.D., Ph. D. | 919-684-3320 | detlev.erdmann@duke.edu |
Locations
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Jody Power 919-668-5111 power008@mc.duke.edu | |
| Principal Investigator: Cynthia Shortell, MD | |
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: | February 4, 2013 |
| 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 June 17, 2013