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Ultrasound to Predict Steal-Syndrome After Arteriovenous-Fistula Creation (UPSAC - Trial) (UPSAC)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468506
First Posted: November 9, 2011
Last Update Posted: September 25, 2014
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.
Information provided by (Responsible Party):
Raul Herrera, MD, Baptist Health South Florida
November 3, 2011
November 9, 2011
September 25, 2014
September 2011
September 2014   (Final data collection date for primary outcome measure)
Steal-Syndrome [ Time Frame: 1 year ]
Steal Syndrome as 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. Standard assessment for steal syndrom at 5-10 days, 4-6 weeks, 6 months, and 1 year.
Same as current
Complete list of historical versions of study NCT01468506 on ClinicalTrials.gov Archive Site
  • Time to fistula maturation [ Time Frame: 1 year ]
    Time between fistula creation and time to clinical fistula maturation, standard assessment of fistula maturation at 5-10 days, 4-6 weeks, 6 months, and 1 year
  • Fistula patency [ Time Frame: 1 year ]
    Time between fistula creation and time to first intervention to restore fistula function (operation, endovascular procedure)
Same as current
Not Provided
Not Provided
 
Ultrasound to Predict Steal-Syndrome After Arteriovenous-Fistula Creation (UPSAC - Trial)
Ultrasound to Predict Steal-Syndrome After Arteriovenous-Fistula Creation (UPSAC - Trial)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients selected for this protocol must have the necessity to undergo surgery to receive an Arterio-Venos Fistula (AVF) for hemodialysis in either arm.
Chronic Kidney Disease
Not Provided
Fistula patients
Consecutive patients with autogenous, brachio-cephalic, brachio-basilic or brachio-brachial arterio-venous fistula creation for hemodialysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01468506
UPSAC version 17 Jul 2011
No
Not Provided
Not Provided
Raul Herrera, MD, Baptist Health South Florida
Baptist Health South Florida
Not Provided
Principal Investigator: Athanassios Tsoukas, MD Baptist Hospital Miami, BCVI
Principal Investigator: Heiko Uthoff, MD Baptist Hospital Miami, BCVI
Principal Investigator: Philipp Geisbuesch, MD Baptist Hospital Miami, BCVI
Study Director: Raul Herrera, MD Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
Principal Investigator: Barry Katzen, MD Medical Director Baptist Cardiac and Vascular Institute
Baptist Health South Florida
September 2014