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

NCT01468506 | Withdrawn

• 1 other identifier: UPSAC version 17 Jul 2011
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; arteriovenous fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to fistula maturation

  1 year

• Fistula patency

  1 year

Study Arms (1)

Fistula patients

Consecutive patients with autogenous, brachio-cephalic, brachio-basilic or brachio-brachial arterio-venous fistula creation for hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Less than 18 years of age
• Patient is unable or unwilling to provide consent
• Prosthetic graft creation

Sponsors & Collaborators

• Baptist Health South Florida: lead

Study Sites (1)

Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Raul Herrera, MD

  Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute

  STUDY DIRECTOR

• Barry Katzen, MD

  Medical Director Baptist Cardiac and Vascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research, Baptist Hospital of Miami, BCVI

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 9, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

US (1)