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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Kidney Disease

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute

Participation Criteria

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

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Fistula patients; Consecutive patients with autogenous, brachio-cephalic, brachio-basilic or brachio-brachial arterio-venous fistula creation for hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steal-Syndrome	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to fistula maturation	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	1 year
Fistula patency	Time between fistula creation and time to first intervention to restore fistula function (operation, endovascular procedure)	1 year

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: November 3, 2011
• First Submitted That Met QC Criteria: November 8, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Estimate): September 25, 2014
• Last Update Submitted That Met QC Criteria: September 23, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; arteriovenous fistula
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Diseases; Renal Insufficiency, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: UPSAC version 17 Jul 2011