Kidney FailureNCT02705417
Maximizing Native Arteriovenous Fistulae Rates.
An observational study of Kidney Failure and Arteriovenous Shunt, run by Medifil AE.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Failure, Arteriovenous Shunt, Hemodialysis
- What is being tested?
- preoperative color Doppler ultrasonographic vascular mapping, physical examination and medical history
- Type of treatment
- Surgery or procedure
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with dialysis dependent end stage renal disease with first time permanent vascular access, more specifically native arteriovenous fistula or arteriovenous grafts.
Who may be able to join
- end stage renal disease
Who cannot join
- poor life expectancy
- congestive heart failure New York Heart Association stage 3 and over
- candidates for tunneled catheters
About this study
Official title: Maximizing Native Arteriovenous Fistulae Rates. Is Routine Colour Doppler Vascular Mapping in Pre-operative Planning of Value? A Retrospective Study.
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.
Read the detailed description
Fistula maturation is a complex vascular remodelling process that requires vessel dilation, increases in volume flow rates in the feeding artery and afferent vein and structural alterations of the vascular wall. The understanding of these procedures and the factors involved in promoting maturation is limited. In this context, one of the major areas requiring investigation is the identification of clinically useful pre-operative predictors of access outcome.
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
- Kidney Failure, Arteriovenous Shunt, Hemodialysis
- Being tested
- preoperative color Doppler ultrasonographic vascular mapping, physical examination, medical history, native arteriovenous fistula construction, arteriovenous graft placement
- Keywords
- arteriovenous fistula, colour Doppler, physical examination, renal dialysis, retrospective studies
- Medical subject headings
- Renal Insufficiency, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative color Doppler ultrasonographic vascular mappingProcedure or surgery
Also called vascular mapping, pre-operative 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 examinationProcedure or surgery
Also called clinical 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 historyProcedure or surgery
medical history with respects to diabetes mellitus, coronary heart disease, peripheral vascular disease
native arteriovenous fistula constructionProcedure or surgery
surgigal creation of native arterial and venous anastomoses
arteriovenous graft placementProcedure or surgery
Also called Polytetrafluoroethylene (PTFE) synthetic graft
surgical placement of arteriovenous graft
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients in whom selection of vascular access relied upon physical examination and medical history, during pre-operative surgical assessment Receives: 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. Receives: Procedure: preoperative color Doppler ultrasonographic vascular mapping; Procedure: physical examination; Procedure: medical history; Procedure: native arteriovenous fistula construction; Procedure: arteriovenous graft placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of native AVF constructed
Measured: in 1 month
Secondary outcomes (1)
primary patency rates
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medifil AE
- Sponsor type
- University, hospital or other
- Collaborators
- International Renal Research Institute Vicenza
- Responsible party
- Principal investigator, Ioannis Emmanouel Giannikouris, Medifil AE
- Investigators
- Ioannis E. Giannikouris, PhD, Principal investigator, Medifil AE Private Hemodialysis Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705417
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Native Arteriovenous Fistulae Rates. Is Routine Colour Doppler Vascular Mapping in Pre-operative Planning of Value? A Retrospective Study.
- ClinicalTrials.gov ID
- NCT02705417
- Acronym / sponsor ID
- 1
- Conditions
- Kidney Failure, Arteriovenous Shunt, Hemodialysis
- Keywords
- arteriovenous fistula, colour Doppler, physical examination, renal dialysis, retrospective studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Medifil AEUniversity, hospital or other
- Collaborators
- International Renal Research Institute Vicenza
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fistula maturation is a complex vascular remodelling process that requires vessel dilation, increases in volume flow rates in the feeding artery and afferent vein and structural alterations of the vascular wall. The understanding of these procedures and the factors involved in promoting maturation is limited. In this context, one of the major areas requiring investigation is the identification of clinically useful pre-operative predictors of access outcome.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: physical examination, Procedure: medical history, Procedure: native arteriovenous fistula construction, Procedure: arteriovenous graft placementPatients in whom selection of vascular access relied upon physical examination and medical history, during pre-operative surgical assessment |
| Group B | – | Procedure: preoperative color Doppler ultrasonographic vascular mapping, Procedure: physical examination, Procedure: medical history, Procedure: native arteriovenous fistula construction, Procedure: arteriovenous graft placementPatients who underwent vascular mapping using color Doppler Ultrasonography in addition to physical examination and history during pre-operative evaluation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with dialysis dependent end stage renal disease with first time permanent vascular access, more specifically native arteriovenous fistula or arteriovenous grafts.
Key inclusion criteria (1 listed)
- end stage renal disease
Key exclusion criteria (3 listed)
- poor life expectancy
- congestive heart failure New York Heart Association stage 3 and over
- candidates for tunneled catheters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative color Doppler ultrasonographic vascular mappingAlso: vascular mapping, pre-operative mappingPreoperative 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. | Procedure or surgery | Group B |
| physical examinationAlso: clinical examinationArterial 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. | Procedure or surgery | Group A, Group B |
| medical historymedical history with respects to diabetes mellitus, coronary heart disease, peripheral vascular disease | Procedure or surgery | Group A, Group B |
| native arteriovenous fistula constructionsurgigal creation of native arterial and venous anastomoses | Procedure or surgery | Group A, Group B |
| arteriovenous graft placementAlso: Polytetrafluoroethylene (PTFE) synthetic graftsurgical placement of arteriovenous graft | Procedure or surgery | Group A, Group B |
Primary outcome
number of native AVF constructed
Time frame: in 1 month
1 secondary outcome
primary patency rates
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis E. Giannikouris, PhD principal investigator
Medifil AE Private Hemodialysis Centre
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure and Arteriovenous Shunt, run by Medifil AE.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of native AVF constructed (time frame: in 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.