Chronic Kidney Diseases Clinical Trial
— DRILOfficial title:
Prospective Hemodynamic Assessment of Distal Revascularization Interval Ligation
Our study seeks to define the effect of each component of the distal revascularization interval ligation (DRIL) procedure on the in vivo distal blood pressure of patients with ischemic steal, and to determine whether the interval ligation component of the DRIL procedure is necessary or not.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2018 |
Est. primary completion date | September 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - >18 yo patients with CKD with a functioning antecubital-based arteriovenous fistula and evidence of ischemic steal as defined above Exclusion Criteria: - Patients identified as undergoing "prophylactic" or "preemptive" DRIL procedure at the time of fistula/graft creation (ie, do not have documented steal at present) - Patients unable to provide informed consent, life expectance of less than one year - Inability to reliably or accurately measure contralateral blood pressures due to heavily calcified vessels documented preoperatively |
Country | Name | City | State |
---|---|---|---|
United States | Tampa General Hospital | Tampa | Florida |
United States | University of South Florida South Tampa Campus | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida |
United States,
Aimaq R, Katz SG. Using distal revascularization with interval ligation as the primary treatment of hand ischemia after dialysis access creation. J Vasc Surg. 2013 Apr;57(4):1073-8; discussion 1078. doi: 10.1016/j.jvs.2012.10.085. — View Citation
Illig KA, Surowiec S, Shortell CK, Davies MG, Rhodes JM, Green RM. Hemodynamics of distal revascularization-interval ligation. Ann Vasc Surg. 2005 Mar;19(2):199-207. — View Citation
Leake AE, Winger DG, Leers SA, Gupta N, Dillavou ED. Management and outcomes of dialysis access-associated steal syndrome. J Vasc Surg. 2015 Mar;61(3):754-60. doi: 10.1016/j.jvs.2014.10.038. — View Citation
Varble N, Day S, Phillips D, Mix D, Schwarz K, Illig KA, Chandra A. In vitro hemodynamic model of the arm arteriovenous circulation to study hemodynamics of native arteriovenous fistula and the distal revascularization and interval ligation procedure. J V — View Citation
Zanow J, Krueger U, Reddemann P, Scholz H. Experimental study of hemodynamics in procedures to treat access-related ischemia. J Vasc Surg. 2008 Dec;48(6):1559-65. doi: 10.1016/j.jvs.2008.06.040. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in forearm pressures | one year | ||
Secondary | Proportion of interval ligation procedures | one year |
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