Ischemia, Vasopressor
Conditions
Keywords
Digital ischemia, Vasopressor
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.
Interventions
DRUGInjection of botulinum toxin A
One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perfusion (as Determined by Laser Doppler Measurements) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Digital Amputations | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Boxtox Injection Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment). | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Boxtox Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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).
Time frame: 12 months
Population: Due to insufficient accrual, data analysis was not performed.
Secondary
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.
Time frame: 12 months
Population: Due to insufficient accrual, data analysis was not performed.