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Hemodynamic Assessment of Distal Revascularization Interval Ligation (DRIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054623
Recruitment Status : Unknown
Verified February 2017 by University of South Florida.
Recruitment status was:  Recruiting
First Posted : February 15, 2017
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Steal Syndrome Chronic Kidney Diseases Arterio-Venous Fistula Procedure: DRIL procedure

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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Hemodynamic Assessment of Distal Revascularization Interval Ligation
Actual Study Start Date : September 20, 2016
Estimated Primary Completion Date : September 20, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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
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.




Primary Outcome Measures :
  1. Difference in forearm pressures [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Proportion of interval ligation procedures [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054623


Contacts
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Contact: Rachel Karlnoski, PhD 813-844-4133 rkarlnos@health.usf.edu
Contact: Thanh Tran, MPH 813-844-8544 thanhtran@health.usf.edu

Locations
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United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Rachel Karlnoski, PhD    813-844-4133    rkarlnos@health.usf.edu   
Contact: Thanh Tran, MPH    813-844-8544    thanhtran@health.usf.edu   
Principal Investigator: Karl Illig, MD         
Sub-Investigator: Mary Ottinger, MD         
Sub-Investigator: Danielle Fontenot, MD         
University of South Florida South Tampa Campus Recruiting
Tampa, Florida, United States, 33606
Contact: Rachel Karlnoski, PhD    813-844-4133    rkarlnos@health.usf.edu   
Contact: Thanh Tran, MPH    8138448544    thanhtran@health.usf.edu   
Principal Investigator: Karl Illig, MD         
Sub-Investigator: Mary Ottinger, MD         
Sub-Investigator: Danielle Fontenot, MD         
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Karl Illig, MD University of South Florida
Publications of Results:
Other Publications:
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03054623    
Other Study ID Numbers: DRIL
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Arteriovenous Fistula
Fistula
Urologic Diseases
Renal Insufficiency
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities