IschemiaNCT01483209
Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
A study testing Injection of botulinum toxin A in people with Ischemia and Vasopressor, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia, Vasopressor
- What is being tested?
- Injection of botulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be admitted to the ICU
- Have digital ischemia and
- Be on a vasopressor infusion
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
- Conditions
- Ischemia, Vasopressor
- Being tested
- Injection of botulinum toxin A
- Keywords
- Digital ischemia, Vasopressor
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of botulinum toxin ADrug
Also called Botox
One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy
| Study group | Role | What they receive |
|---|---|---|
| Botox injection | Experimental | Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia Receives: Drug: Injection of botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IschemiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Shortell, MD, Principal investigator, Duke UMCDetlev Erdmann, M.D., Ph. D., Study director, Duke UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483209
- Sponsor's protocol ID
- Pro00032002
- Status last verified
- Feb 2015
- First submitted
- 29 Nov 2011
- Last updated
- 2 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
- ClinicalTrials.gov ID
- NCT01483209
- Acronym / sponsor ID
- Pro00032002
- Conditions
- Ischemia, Vasopressor
- Keywords
- Digital ischemia, Vasopressor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Posted 2 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botox injection | Experimental | Drug: Injection of botulinum toxin AUse of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be admitted to the ICU
- Have digital ischemia and
- Be on a vasopressor infusion
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of botulinum toxin AAlso: BotoxOne-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy | Drug | Botox injection |
Primary outcome
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).
1 secondary outcome
Digital Amputations
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Shortell, MD principal investigator
Duke UMC
Detlev Erdmann, M.D., Ph. D. study director
Duke UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of botulinum toxin A in people with Ischemia and Vasopressor, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion (as Determined by Laser Doppler Measurements) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.