Hemodynamic Assessment of Distal Revascularization Interval Ligation (DRIL)

February 13, 2017 updated by: University of South Florida

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.

Study Overview

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.

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult (>18 yo) patients with chronic kidney disease with functioning antecubital-based arteriovenous fistulae and evidence of ischemic steal symptoms

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karl Illig, MD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2016

Primary Completion (Anticipated)

September 20, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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