Hemodynamic Assessment of Distal Revascularization Interval Ligation

Chronic Kidney Diseases Clinical Trial

— DRIL  

Official title:

Prospective Hemodynamic Assessment of Distal Revascularization Interval Ligation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03054623
• Other study ID #: DRIL
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2017
• Last updated: February 13, 2017
• Start date: September 20, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2017
• Source: University of South Florida
• Contact: Rachel Karlnoski, PhD
• Phone: 813-844-4133
• Email: rkarlnos[@]health.usf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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):

1. After surgical exposure but before any intervention has been performed,

2. 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.

3. After performance of the distal revascularization (DR) but BEFORE interval ligation of the brachial artery.

4. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arterio-Venous Fistula
• Arteriovenous Fistula
• Chronic Kidney Diseases
• Fistula
• Kidney Diseases
• Renal Insufficiency, Chronic
• Steal Syndrome

Intervention

Procedure:
• DRIL procedure
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.

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida
United States	University of South Florida South Tampa Campus	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in forearm pressures		one year
Secondary	Proportion of interval ligation procedures		one year