Catocholamine Induced Finger Necrosis Clinical Trial
Official title:
Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.
Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive drugs such as amines. Finger necrosis (so called "blue toe syndrome") is a well documented phenomena with incidence reaching as high as 60% in patients receiving vasopressin. Botulinum toxin is a known muscle relaxant used for a variety of medical application. Recently, several reports have demonstrated its effect in vasospastic disorders. It has also been in mice that when administered locally it has a local vasodilatory effect. The goal of this experiment is to compare the effect of Botulinum Toxin administered locally on amine induced finger necrosis.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients treated with vasoactive drugs (amines) and have finger/toe necrosis Exclusion Criteria: - Sensitivity to drug (Botox) ingredients. - Active local limb infection - ICU admission due to botulism - Chronic muscular weakness disease, e.g., Myasthenia gravis, ALS - Age lower than 18 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Sheba Medical Center | Tel-Hashomer |
| Lead Sponsor | Collaborator |
|---|---|
| Sheba Medical Center |
Israel,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | index of Toe and Finger Ischemia (iTFI) | Score including: O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration |
three months after drug administration | No |
| Secondary | Amputation | Amputations performed - fingers, toe and limb - height and number of amputations | Three months after drug administration | No |
| Secondary | Patients survival | Survival | Three months after drug administration | Yes |