Maximizing Native Arteriovenous Fistulae Rates.

NCT02705417 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of our study is to compare physical examination alone to color Doppler ultrasonography (CDUS) vascular mapping and physical examination in terms of outcomes of vascular access and long-term patency.

Conditions

Kidney Failure; Arteriovenous Shunt; Hemodialysis

Keywords

arteriovenous fistula; colour Doppler; physical examination; renal dialysis; retrospective studies

Outcome Measures

Primary Outcomes (1)

• number of native AVF constructed

  in 1 month

Secondary Outcomes (1)

• primary patency rates

  12 months

Study Arms (2)

Group A

Patients in whom selection of vascular access relied upon physical examination and medical history, during pre-operative surgical assessment

Procedure: physical examination; Procedure: medical history; Procedure: native arteriovenous fistula construction; Procedure: arteriovenous graft placement

Group B

Patients who underwent vascular mapping using color Doppler Ultrasonography in addition to physical examination and history during pre-operative evaluation.

Procedure: preoperative color Doppler ultrasonographic vascular mapping; Procedure: physical examination; Procedure: medical history; Procedure: native arteriovenous fistula construction; Procedure: arteriovenous graft placement

Interventions

preoperative color Doppler ultrasonographic vascular mapping PROCEDURE

Preoperative color Doppler ultrasonographic vascular mapping was performed with linear probe. The patient extremity under scrutiny was placed under support, with tourniquet augmentation. Vessels were examined in both short (transverse) and long (longitudinal) axis. Anatomical variations, wall morphology and internal diameters at the antecubital fossa, the proximal (cranial), mid and distal (caudal) third of the arm and forearm were assessed in both extremities. Veins were evaluated for compressibility and adequate drainage to deep venous system. The presence of sclerotic, thrombosed and fibrosed segments were noted. Doppler waveforms were obtained in the long axis and volume flow (VF) calculated for arteries selected for potential access construction.

Also known as: vascular mapping, pre-operative mapping

Group B

physical examination PROCEDURE

Arterial pulse examination, differential blood pressure measurements and the Allen test in both extremities. Inspection of the superficial venous system with tourniquet enhancement in the arm was performed during venous assessment.

Also known as: clinical examination

Group A; Group B

medical history PROCEDURE

medical history with respects to diabetes mellitus, coronary heart disease, peripheral vascular disease

Group A; Group B

native arteriovenous fistula construction PROCEDURE

surgigal creation of native arterial and venous anastomoses

Group A; Group B

arteriovenous graft placement PROCEDURE

surgical placement of arteriovenous graft

Also known as: Polytetrafluoroethylene (PTFE) synthetic graft

Group A; Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with dialysis dependent end stage renal disease with first time permanent vascular access, more specifically native arteriovenous fistula or arteriovenous grafts.

You may qualify if:

• end stage renal disease

You may not qualify if:

• poor life expectancy
• congestive heart failure New York Heart Association stage 3 and over
• candidates for tunneled catheters

Sponsors & Collaborators

• Medifil AE: lead
• International Renal Research Institute Vicenza: collaborator

MeSH Terms

Conditions

Renal Insufficiency; Arteriovenous Fistula

Interventions

Restraint, Physical; Health Records, Personal; Polytetrafluoroethylene

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; 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; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Medical Records; Records; Data Collection; Epidemiologic Methods; Fluorocarbon Polymers; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ioannis E. Giannikouris, PhD

  Medifil AE Private Hemodialysis Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant for the Medical Director

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 10, 2016
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 10, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share