View Clinical Trial (Medical Research Study)
Ultrasound to Predict Steal-Syndrome After Arteriovenous-Fistula Creation (UPSAC - Trial)
| City: |
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Miami |
| State: |
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Florida |
| Zip Code: |
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33176 |
| Conditions: |
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Chronic Kidney Disease |
| Purpose: |
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The purpose of this study is to analyze and identify pre-, intra-, and post- operative
parameters that predict Steal-Syndrome with distal malperfusion after Arterio-Venous
Fistulas (AVF) as primary endpoint. Secondary endpoints are pre-, intra-, and post-
operative parameters that predict patency and fistula maturation.
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| Study Summary: |
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This is a prospective study where the research team will acquire data from the patients
after they have signed the informed consent form. Data will be collected before, during and
after the Arterio-Venous Fistula(AVF)placement, and during follow-up at predefined time
intervals:Pre-Operative, Intra-operative, Post-operative, 5-10 days, 4-6 Weeks, 6 Months,
and 1 year. These parameters include Digital Brachial Index (DBI) (assessed by Doppler
derived brachial artery blood pressure/ photoplethysmographically derived finger blood
pressure), flow and pulsatility measurements (derived by duplex ultrasound and pulse volume
recording). Assessment of flow and pulsatility will be performed in the artery proximal and
distal to the AVF, as well as in the venous outflow. In addition, Demographic parameters and
patient comorbidities will be acquired and procedure specific parameters (e.g. location of
the fistula) will be documented. During each follow up, clinical evaluation for
Steal-Syndrome will be conducted. Steal-Syndrome was defined according to the guidelines of
the Society of Vascular Surgery (SVS): Asymptomatic (pulse deficits, doppler signal
attenuation, and distal flow reversal) Mild Ischemia: slight coldness and numbness that
occurs only during dialysis, may be self-limited, and may resosolve without treatment, and
Severe Ischemia: Can be permanent and may be associated with constant pain, severe numbness,
digital cyanosis or gangrene, finger contracture, or amputation of a digit hand or forearm.
The necessity for and type of re-intervention at the AVF will be documented. Acquisition of
data will in no way change the standard of care used in these patients / operations.
Data analysis will be performed after enrolment of 100, 250 and 500 patients.
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| Criteria: |
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Inclusion Criteria:
- Patients 18 years of age
- Autogenous, brachio-cephalic, brachio-basilic or brachio-brachial Arterio- Venous
Fistula creation for hemodialysis
- General preoperative requirements for this surgery passed
- Patients willing to adhere to the follow-up
- Patients able to understand and provide informed consent
Exclusion Criteria:
- Less than 18 years of age
- Patient is unable or unwilling to provide consent
- Prosthetic graft creation
- Creation of a radio-cephalic AV-Fistula other than described in the inclusion
criteria
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| NCT ID: |
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NCT01468506 |
| Primary Contact: |
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Principal Investigator
Athanassios Tsoukas, MD
Baptist Hospital Miami, BCVI
Athanassios Tsoukas, M.D.
Phone: 305-274-2030
Email: tsoukas@pol.net
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| Backup Contact: |
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Email: heikou@baptisthealth.net
Heiko Uthoff, M.D.
Phone: 786-246-6068
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| Location Contact: |
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Miami, Florida 33176
United States
Athanassios Tsoukas, M.D.
Phone: 305-274-2030
Email: tsoukas@pol.net
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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