Hemodynamic Assessment of Distal Revascularization Interval Ligation
- Conditions
- Chronic Kidney DiseasesArterio-Venous FistulaSteal Syndrome
- Interventions
- Procedure: DRIL procedure
- Registration Number
- NCT03054623
- Lead Sponsor
- University of South Florida
- Brief 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.
- 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):
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 & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- >18 yo patients with CKD with a functioning antecubital-based arteriovenous fistula and evidence of ischemic steal as defined above
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description DRIL procedure DRIL procedure Adult (\>18 yo) patients with chronic kidney disease with functioning antecubital-based arteriovenous fistulae and evidence of ischemic steal symptoms
- Primary Outcome Measures
Name Time Method Difference in forearm pressures one year
- Secondary Outcome Measures
Name Time Method Proportion of interval ligation procedures one year
Trial Locations
- Locations (2)
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of South Florida South Tampa Campus
🇺🇸Tampa, Florida, United States