- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03054623
Hemodynamic Assessment of Distal Revascularization Interval Ligation (DRIL)
Prospective Hemodynamic Assessment of Distal Revascularization Interval Ligation
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will involve identification of patients with ischemic steal who are deemed candidates for distal revascularization with interval ligation (DRIL), followed by prospective data collection of intraoperative noninvasive data at key points in the operation.
After informed consent, chart review will be performed to identify patient characteristics as well as details of their presentation of steal syndrome, including symptomatology, duration, characteristics of contributory arteriovenous access, and preoperative data including upper extremity/forearm pressures, fistula flow data, and finger pressures with and without fistula compression.
Patients will have noninvasive intraoperative measurement of bilateral forearm blood pressure measurements using automated blood pressure cuffs within sterile bands on the operative side as well as the contralateral ("control") side. Automated blood pressure measurements will then be performed at four time points in the operation, simultaneously on both arms (operative versus control):
- After surgical exposure but before any intervention has been performed,
- After clamping of the brachial artery after dissection and control of the vessel to assess for the effect of interval ligation (IL) alone on the forearm blood pressure.
- After performance of the distal revascularization (DR) but BEFORE interval ligation of the brachial artery.
- After completion of the procedure, including both distal revascularization AND interval ligation (DRIL).
The performance of blood pressure measurements will not alter the performance of the operation, nor will this have any influence on intraoperative decision-making. Intraoperative patient positioning and set-up will be unaffected by the addition of a distal forearm blood pressure cuff for data acquisition. Neither the pre-operative selection or post-operative care will be influenced by participation in this study, nor by the data acquired. It should be noted that this technique is intermittently used as standard of care when needed in current practice.
Patients will be assessed for symptom improvement and DRIL patency at their standard 14 day, 3 month, 6 month, 9 month and 1 year follow up visits.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33606
- Recruiting
- Tampa General Hospital
-
Sub-Investigator:
- Mary Ottinger, MD
-
Sub-Investigator:
- Danielle Fontenot, MD
-
Tampa, Florida, United States, 33606
- Recruiting
- University of South Florida South Tampa Campus
-
Sub-Investigator:
- Mary Ottinger, MD
-
Sub-Investigator:
- Danielle Fontenot, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
DRIL procedure
Adult (>18 yo) patients with chronic kidney disease with functioning antecubital-based arteriovenous fistulae and evidence of ischemic steal symptoms
|
The DRIL procedure involves creation of a bypass from an arterial inflow site (usually mid brachial artery) proximal to the fistula inflow, to the bifurcation of the brachial artery distal to the fistula, with ligation of the intervening native vessel, thus restoring distal flow while preserving flow through the fistula.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in forearm pressures
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of interval ligation procedures
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karl Illig, MD, University of South Florida
Publications and helpful links
General Publications
- 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. Epub 2008 Sep 4.
- 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. Epub 2013 Jan 29.
- 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. Epub 2014 Dec 9.
- 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. doi: 10.1007/s10016-004-0162-y.
- 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 Vasc Surg. 2014 May;59(5):1410-7. doi: 10.1016/j.jvs.2013.04.055. Epub 2013 Jul 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Congenital Abnormalities
- Renal Insufficiency
- Pathological Conditions, Anatomical
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Kidney Diseases
- Renal Insufficiency, Chronic
- Fistula
- Arteriovenous Fistula
Other Study ID Numbers
- DRIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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