Study Results
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Basic Information
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COMPLETED
136 participants
OBSERVATIONAL
2012-01-31
2015-01-31
Brief Summary
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Detailed Description
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Traditionally, the selection of vascular access and the eligibility for native arteriovenous fistula construction was mainly determined by findings of clinical examination. However, in addition to a complete history and physical examination, National Kidney Foundation/Dialysis Outcome Quality Initiative (NFK/DOQI) recommended that routine pre-operative color Doppler ultrasonographic vascular mapping should be performed in all hemodialysis patients who are candidates for access formation. This concerns the routine implementation of a non-invasive, safe and cost-effective method that permits the identification of vessels that are suitable for arteriovenous fistula (AVF) construction, acknowledging that supporting Level I evidence is still lacking. Indeed, available data supporting the significance of mapping on access maturation and patency rates are limited and conflicting.
The aim of the present study is to compare the type of preoperative assessment, physical examination alone to combined CDUS vascular mapping and physical examination, to outcomes of performed vascular access procedures with respect to type selection and long-term patency at 12 months in hemodialysis patients.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Group A
Patients in whom selection of vascular access relied upon physical examination and medical history, during pre-operative surgical assessment
physical examination
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.
medical history
medical history with respects to diabetes mellitus, coronary heart disease, peripheral vascular disease
native arteriovenous fistula construction
surgigal creation of native arterial and venous anastomoses
arteriovenous graft placement
surgical placement of arteriovenous graft
Group B
Patients who underwent vascular mapping using color Doppler Ultrasonography in addition to physical examination and history during pre-operative evaluation.
preoperative color Doppler ultrasonographic vascular mapping
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.
physical examination
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.
medical history
medical history with respects to diabetes mellitus, coronary heart disease, peripheral vascular disease
native arteriovenous fistula construction
surgigal creation of native arterial and venous anastomoses
arteriovenous graft placement
surgical placement of arteriovenous graft
Interventions
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preoperative color Doppler ultrasonographic vascular mapping
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.
physical examination
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.
medical history
medical history with respects to diabetes mellitus, coronary heart disease, peripheral vascular disease
native arteriovenous fistula construction
surgigal creation of native arterial and venous anastomoses
arteriovenous graft placement
surgical placement of arteriovenous graft
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* congestive heart failure New York Heart Association stage 3 and over
* candidates for tunneled catheters
ALL
No
Sponsors
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International Renal Research Institute Vicenza
OTHER
Medifil AE
OTHER
Responsible Party
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Ioannis Emmanouel Giannikouris
Assistant for the Medical Director
Principal Investigators
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Ioannis E. Giannikouris, PhD
Role: PRINCIPAL_INVESTIGATOR
Medifil AE Private Hemodialysis Centre
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id
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