Clinical trial NCT01468506: Ultrasound to Predict Steal-Syndrome After Arteriovenous-Fistula Creation (UPSAC - Trial)
Official title: Ultrasound to Predict Steal-Syndrome After Arteriovenous-Fistula Creation (UPSAC - Trial)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
arteriovenous fistula
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: Steal-Syndrome
timeFrame: 1 year
Secondary outcomes:
measure: Time to fistula maturation
timeFrame: 1 year
measure: Fistula patency
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
state: Florida
Study officials:
affiliation: Baptist Hospital Miami, BCVI
name: Athanassios Tsoukas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Hospital Miami, BCVI
name: Heiko Uthoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Hospital Miami, BCVI
name: Philipp Geisbuesch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
name: Raul Herrera, MD
role: STUDY_DIRECTOR
affiliation: Medical Director Baptist Cardiac and Vascular Institute
name: Barry Katzen, MD
role: PRINCIPAL_INVESTIGATOR
References: