Clinical trial NCT01500668: Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis
Official title: Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Catocholamine Induced Finger Necrosis
Keywords: Botox
catocholamine
shock
vasomotor
Vasopressin
botulinum toxin
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-12-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: index of Toe and Finger Ischemia (iTFI)
timeFrame: three months after drug administration
Secondary outcomes:
measure: Amputation
timeFrame: Three months after drug administration
measure: Patients survival
timeFrame: Three months after drug administration
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Amir Herman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunser MW, Mayr AJ, Tur A, Pajk W, Barbara F, Knotzer H, Ulmer H, Hasibeder WR. Ischemic skin lesions as a complication of continuous vasopressin infusion in catecholamine-resistant vasodilatory shock: incidence and risk factors. Crit Care Med. 2003 May;31(5):1394-8. doi: 10.1097/01.CCM.0000059722.94182.79.
citation: Fregene A, Ditmars D, Siddiqui A. Botulinum toxin type A: a treatment option for digital ischemia in patients with Raynaud's phenomenon. J Hand Surg Am. 2009 Mar;34(3):446-52. doi: 10.1016/j.jhsa.2008.11.026.
citation: Golbranson FL, Lurie L, Vance RM, Vandell RF. Multiple extremity amputations in hypotensive patients treated with dopamine. JAMA. 1980 Mar 21;243(11):1145-6.
citation: Van Beek AL, Lim PK, Gear AJL, Pritzker MR. Management of vasospastic disorders with botulinum toxin A. Plast Reconstr Surg. 2007 Jan;119(1):217-226. doi: 10.1097/01.prs.0000244860.00674.57.
citation: Janz BA, Thomas PR, Fanua SP, Dunn RE, Wilgis EF, Means KR Jr. Prevention of anastomotic thrombosis by botulinum toxin B after acute injury in a rat model. J Hand Surg Am. 2011 Oct;36(10):1585-91. doi: 10.1016/j.jhsa.2011.07.008. Epub 2011 Aug 19.
citation: Clemens MW, Higgins JP, Wilgis EFS. Prevention of anastomotic thrombosis by botulinum toxin a in an animal model. Plast Reconstr Surg. 2009 Jan;123(1):64-70. doi: 10.1097/PRS.0b013e3181904c31.