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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Baptist Health South Florida
Sponsor:
Information provided by (Responsible Party):
Raul Herrera, MD, Baptist Health South Florida
ClinicalTrials.gov Identifier:
NCT01468506
First received: November 3, 2011
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound to Predict Steal-Syndrome After Arteriovenous-Fistula Creation (UPSAC - Trial)

Resource links provided by NLM:


Further study details as provided by Baptist Health South Florida:

Primary Outcome Measures:
  • Steal-Syndrome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to fistula maturation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time between fistula creation and time to first intervention to restore fistula function (operation, endovascular procedure)


Estimated Enrollment: 500
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fistula patients
Consecutive patients with autogenous, brachio-cephalic, brachio-basilic or brachio-brachial arterio-venous fistula creation for hemodialysis

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients selected for this protocol must have the necessity to undergo surgery to receive an Arterio-Venos Fistula (AVF) for hemodialysis in either arm.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468506

Contacts
Contact: Athanassios Tsoukas, M.D. 305-274-2030 tsoukas@pol.net
Contact: Heiko Uthoff, M.D. 786-246-6068 heikou@baptisthealth.net

Locations
United States, Florida
Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute Recruiting
Miami, Florida, United States, 33176
Contact: Athanassios Tsoukas, M.D.    305-274-2030    tsoukas@pol.net   
Contact: Heiko Uthoff, M.D.    786-246-6068    heikou@baptisthealth.net   
Principal Investigator: Athanassios Tsoukas, M.D.         
Principal Investigator: Heiko Uthoff, M.D.         
Sub-Investigator: James Benenati, M.D.         
Sub-Investigator: Barry T Katzen, M.D.         
Sub-Investigator: Dillon Arango, MD Candidate         
Principal Investigator: Philipp Geisbuesch, MD         
Sponsors and Collaborators
Baptist Health South Florida
Investigators
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
  More Information

No publications provided

Responsible Party: Raul Herrera, MD, Director of Clinical Research, Baptist Hospital of Miami, BCVI, Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT01468506     History of Changes
Other Study ID Numbers: UPSAC version 17 Jul 2011
Study First Received: November 3, 2011
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baptist Health South Florida:
Chronic Kidney Disease
arteriovenous fistula

Additional relevant MeSH terms:
Arteriovenous Malformations
Arteriovenous Fistula
Fistula
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 26, 2014