Arteriovenous FistulaNCT06262659
The Effect of Ultrasonography on Blood Flow,Vessel Diameter,and Depth Measurements in Dialysis Patients With Fistula
An observational study of Arteriovenous Fistula, run by Kudret Atakan Tekin at 1 site in Turkey (Türkiye).
Trial summary
Arteriovenous fistulas (AVF) are considered essential and the primary vascular access for end-stage renal disease patients to receive hemodialysis (HD) treatment. The maturation failure rate of AVFs is approximately 23%. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Doppler Ultrasonography Assessment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2024to 10 Sep 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing the first-time autologous arteriovenous fistula creation surgery in end-stage renal failure will be included in the study.
Who may be able to join
- Patients in need of AVF for hemodialysis due to end-stage renal failure,
- Patients aged 18 and older but younger than 70,
- Patients who have not undergone dialysis before,
- Patients with normal sinus rhythm on EKG,
- Patients with triphasic flow in upper extremity arterial Doppler ultrasonography,
- Patients with a minimum vessel diameter of ≥2 mm for arteries and ≥2.5 mm for veins on Doppler ultrasonography.
Who cannot join
- Patients with reduced ejection fraction (EF) (<50%),
- Patients with heart valve disease,
- Patients with coronary artery disease or those who have undergone coronary artery bypass grafting surgery,
- Patients with a history of fistula creation,
- Patients undergoing fistula revision,
- Patients with peripheral vascular disease,
Show all 12Show fewer
- Patients with venous embolism/thrombosis or occlusion history in the upper extremity superficial/deep venous system, superior vena cava,
- Patients with arterial embolism or occlusion in the upper extremity,
- Patients with burn scars in the upper extremity,
- Patients with atrophy/paralysis/plegia in the upper extremity,
- Patients with uncontrolled diabetes,
- Patients with connective tissue disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Blood Flow, Vascular Diameter, And Depth Measurements With Intraoperative Doppler Ultrasonography On Arteriovenous Fistula Maturation In Dialysis Patients: A Prospective Study
Arteriovenous fistulas (AVF) are considered essential and the primary vascular access for end-stage renal disease patients to receive hemodialysis (HD) treatment. The maturation failure rate of AVFs is approximately 23%. The aim of our study is to compare intraoperative fistula flow and measurements of vascular structures' diameters with postoperative fistula maturation, following the completion of the fistula operation, to reveal the relationship between them. Providing insights into the need for intraoperative intervention and/or postoperative fistula management based on these measurements is intended to contribute to the literature by offering predictions and perspectives.
Read the detailed description
Arteriovenous fistulas (AVF) are generally acknowledged as the 'gold standard' for hemodialysis (HD) access in end-stage renal disease patients. While they exhibit the most successful performance, their lifespan is longer compared to other access types, and the infection and hospitalization rates are lower. However, it is known that many newly created fistulas do not mature to a level that provides sufficient HD access. There is no universal definition for a matured AVF, and the method adopted in the updated National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines is widely used. KDOQI has defined the "6s rule" to describe maturation (a flow rate of 600 ml/min, an AVF located within 6 millimeters from the skin surface to facilitate successful and repeatable cannulation by HD staff, and finally, a minimum diameter of 6 millimeters). A matured AVF should be continuously cannulated and allow a minimum blood flow of 300-400 ml per minute. Various patient factors, including Diabetes Mellitus (DM), female gender, and age, have been suggested to be associated with poor AVF maturation. However, these factors are less important when preoperative ultrasound mapping of the relevant arterial and venous region shows vessels of sufficient size. Preoperative ultrasound venous mapping has been proven to significantly assist in deciding on an AVF with a higher chance of successful maturation. Surgical or endovascular intervention is frequently required for AVFs that do not mature or to facilitate maturation. Even after successful AVF maturation, interventions are often needed to maintain long-term patency in hemodialysis. The maturation of AVF typically takes between 6 to 8 weeks. Previous studies have evaluated postoperative ultrasound criteria to assess AVF maturation and determine the need for interventions that would promote maturation. These studies reported high predictive values for AVF maturation using postoperative blood flow thresholds of 420-800 ml/min or diameters of 3.6-5.4 mm. However, the generalizability of these studies is limited due to the relatively small number of patients, the prevalence of radiocephalic AVFs, and variable definitions of AVF maturation. While published studies have focused on the value of postoperative AVF ultrasound measurements in predicting maturation, none have assessed the predictive value for determining primary patency (the time until the first intervention when the AVF achieves independent maturation). Venous diameter maturity is an independent determinant, and a venous diameter less than 2.5 mm is often associated with non-maturation, especially if the vein cannot expand after tourniquet application; a preoperative ultrasound measurement of a vein ≥4 mm is expected to result in successful maturation. A series of 158 patients reported that venous diameter was the main independent determinant of functional maturation, and it was the only independent variable. NKF-KDOQI guidelines suggest allowing a fistula to mature for at least one month before cannulation. Cannulating within 14 days after AVF creation reduces long-term fistula survival and increases the risk of subsequent fistula failure by 2.1 times compared to fistulas cannulated after 14 days. Fistulas cannulated between 15 and 28 days showed no significant difference in non-maturation rates compared to those cannulated after 43 to 84 days. Ultrasound is a non-invasive imaging technology that can significantly contribute to understanding vascular anatomy in the context of dialysis access. Depth measurements and flow volume detections in arterial flow, in particular, can guide interventions. Postoperative ultrasound is commonly used to assess AVF maturation for hemodialysis.
- Conditions
- Arteriovenous Fistula
- Being tested
- Doppler Ultrasonography Assessment
- Keywords
- arteriovenous fistula, fistula flow, vascular diameter, intraoperative Doppler Ultrasound, arteriovenous fistula maturation
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler Ultrasonography AssessmentOther
Preoperative data will be collected from the latest available data within the last month. Preoperative Doppler ultrasonography venous mapping for all patients will be performed by experienced Radiology Specialists.
AVF flow measurement will be performed intraoperatively and at the 6th week postoperatively using Doppler ultrasonography (B-Mode and duplex ultrasound on the LOQIC; GE Healthcare Technologies, Milwaukee, Wisconsin, United States). For each patient, AVF flows will be recorded by taking at least 3 measurements of AVF flow, depth, and vascular diameters at 2, 5, 10, and 15 cm proximal to the AVF anastomosis, and arithmetic averages will be calculated. AVF flow will be expressed in "ml/min," and the vascular structure diameters and the distance of AVF from the skin will be indicated in "mm." AVF depth will be calculated as the distance from the skin to the anterior wall of the AVF.
| Study group | Role | What they receive |
|---|---|---|
| group fistula | Preoperative age, gender, weight, height, body mass index, diabetes mellitus, hypertension, asthma, smoking status, postoperative chest pain, intraoperative AVF flow, AVF depth, AVF vascular diameter, and postoperative 6th-week Doppler ultrasonography measurements of AVF flow, AVF depth, and AVF vascular diameter will be recorded for the patients included in the study. Maturation assessment will be made based on these results.
AVF flow measurement will be performed intraoperatively and at the 6th week postoperatively using Doppler ultrasonography (B-Mode and duplex ultrasound on the LOQIC; GE Healthcare Technologies, Milwaukee, Wisconsin, United States). For each patient, AVF flows will be recorded by taking at least 3 measurements of AVF flow, depth, and vascular diameters at 2, 5, 10, and 15 cm proximal to the AVF anastomosis, and arithmetic averages will be calculated. Receives: Other: Doppler Ultrasonography Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative Arteriovenous Fistula Flow Measurement
AVF flow measurement will be conducted intraoperatively using Doppler ultrasonography (B-Mode and duplex ultrasound on the LOQIC; GE Healthcare Technologies, Milwaukee, Wisconsin, United States). For each patient, AVF flows will be recorded by taking at least 3 measurements of AVF flow, at 2, 5, 10, and 15 cm proximal to the AVF anastomosis, and arithmetic averages will be calculated. AVF flow will be expressed in "ml/min".
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start8 Mar 2024
- Primary completion10 Jun 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kudret Atakan Tekin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kudret Atakan Tekin, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262659
- Sponsor's protocol ID
- 2023-142
- Status last verified
- Dec 2024
- First submitted
- 5 Feb 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Blood Flow, Vascular Diameter, And Depth Measurements With Intraoperative Doppler Ultrasonography On Arteriovenous Fistula Maturation In Dialysis Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT06262659
- Acronym / sponsor ID
- 2023-142
- Conditions
- Arteriovenous Fistula
- Keywords
- arteriovenous fistula, fistula flow, vascular diameter, intraoperative Doppler Ultrasound, arteriovenous fistula maturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kudret Atakan TekinUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 16 Feb 2024 (actual)
- 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.
Arteriovenous fistulas (AVF) are considered essential and the primary vascular access for end-stage renal disease patients to receive hemodialysis (HD) treatment. The maturation failure rate of AVFs is approximately 23%. The aim of our study is to compare intraoperative fistula flow and measurements of vascular structures' diameters with postoperative fistula maturation, following the completion of the fistula operation, to reveal the relationship between them. Providing insights into the need for intraoperative intervention and/or postoperative fistula management based on these measurements is intended to contribute to the literature by offering predictions and perspectives.
Detailed description
Arteriovenous fistulas (AVF) are generally acknowledged as the 'gold standard' for hemodialysis (HD) access in end-stage renal disease patients. While they exhibit the most successful performance, their lifespan is longer compared to other access types, and the infection and hospitalization rates are lower. However, it is known that many newly created fistulas do not mature to a level that provides sufficient HD access. There is no universal definition for a matured AVF, and the method adopted in the updated National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines is widely used. KDOQI has defined the "6s rule" to describe maturation (a flow rate of 600 ml/min, an AVF located within 6 millimeters from the skin surface to facilitate successful and repeatable cannulation by HD staff, and finally, a minimum diameter of 6 millimeters). A matured AVF should be continuously cannulated and allow a minimum blood flow of 300-400 ml per minute. Various patient factors, including Diabetes Mellitus (DM), female gender, and age, have been suggested to be associated with poor AVF maturation. However, these factors are less important when preoperative ultrasound mapping of the relevant arterial and venous region shows vessels of sufficient size. Preoperative ultrasound venous mapping has been proven to significantly assist in deciding on an AVF with a higher chance of successful maturation. Surgical or endovascular intervention is frequently required for AVFs that do not mature or to facilitate maturation. Even after successful AVF maturation, interventions are often needed to maintain long-term patency in hemodialysis. The maturation of AVF typically takes between 6 to 8 weeks. Previous studies have evaluated postoperative ultrasound criteria to assess AVF maturation and determine the need for interventions that would promote maturation. These studies reported high predictive values for AVF maturation using postoperative blood flow thresholds of 420-800 ml/min or diameters of 3.6-5.4 mm. However, the generalizability of these studies is limited due to the relatively small number of patients, the prevalence of radiocephalic AVFs, and variable definitions of AVF maturation. While published studies have focused on the value of postoperative AVF ultrasound measurements in predicting maturation, none have assessed the predictive value for determining primary patency (the time until the first intervention when the AVF achieves independent maturation). Venous diameter maturity is an independent determinant, and a venous diameter less than 2.5 mm is often associated with non-maturation, especially if the vein cannot expand after tourniquet application; a preoperative ultrasound measurement of a vein ≥4 mm is expected to result in successful maturation. A series of 158 patients reported that venous diameter was the main independent determinant of functional maturation, and it was the only independent variable. NKF-KDOQI guidelines suggest allowing a fistula to mature for at least one month before cannulation. Cannulating within 14 days after AVF creation reduces long-term fistula survival and increases the risk of subsequent fistula failure by 2.1 times compared to fistulas cannulated after 14 days. Fistulas cannulated between 15 and 28 days showed no significant difference in non-maturation rates compared to those cannulated after 43 to 84 days. Ultrasound is a non-invasive imaging technology that can significantly contribute to understanding vascular anatomy in the context of dialysis access. Depth measurements and flow volume detections in arterial flow, in particular, can guide interventions. Postoperative ultrasound is commonly used to assess AVF maturation for hemodialysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group fistula | – | Other: Doppler Ultrasonography AssessmentPreoperative age, gender, weight, height, body mass index, diabetes mellitus, hypertension, asthma, smoking status, postoperative chest pain, intraoperative AVF flow, AVF depth, AVF vascular diameter, and postoperative 6th-week Doppler ultrasonography measurements of AVF flow, AVF depth, and AVF vascular diameter will be recorded for the patients included in the study. Maturation assessment will be made based on these results. AVF flow measurement will be performed intraoperatively and at the 6th week postoperatively using Doppler ultrasonography (B-Mode and duplex ultrasound on the LOQIC; GE Healthcare Technologies, Milwaukee, Wisconsin, United States). For each patient, AVF flows will be recorded by taking at least 3 measurements of AVF flow, depth, and vascular diameters at 2, 5, 10, and 15 cm proximal to the AVF anastomosis, and arithmetic averages will be calculated. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing the first-time autologous arteriovenous fistula creation surgery in end-stage renal failure will be included in the study.
Key inclusion criteria (6 listed)
- Patients in need of AVF for hemodialysis due to end-stage renal failure,
- Patients aged 18 and older but younger than 70,
- Patients who have not undergone dialysis before,
- Patients with normal sinus rhythm on EKG,
- Patients with triphasic flow in upper extremity arterial Doppler ultrasonography,
Key exclusion criteria (12 listed)
- Patients with reduced ejection fraction (EF) (<50%),
- Patients with heart valve disease,
- Patients with coronary artery disease or those who have undergone coronary artery bypass grafting surgery,
- Patients with a history of fistula creation,
- Patients undergoing fistula revision,
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 |
|---|---|---|
| Doppler Ultrasonography AssessmentPreoperative data will be collected from the latest available data within the last month. Preoperative Doppler ultrasonography venous mapping for all patients will be performed by experienced Radiology Specialists. AVF flow measurement will be performed intraoperatively and at the 6th week postoperatively using Doppler ultrasonography (B-Mode and duplex ultrasound on the LOQIC; GE Healthcare Technologies, Milwaukee, Wisconsin, United States). For each patient, AVF flows will be recorded by taking at least 3 measurements of AVF flow, depth, and vascular diameters at 2, 5, 10, and 15 cm proximal to the AVF anastomosis, and arithmetic averages will be calculated. AVF flow will be expressed in "ml/min," and the vascular structure diameters and the distance of AVF from the skin will be indicated in "mm." AVF depth will be calculated as the distance from the skin to the anterior wall of the AVF. | Other | group fistula |
Primary outcome
intraoperative Arteriovenous Fistula Flow Measurement
Time frame: 1 hour
AVF flow measurement will be conducted intraoperatively using Doppler ultrasonography (B-Mode and duplex ultrasound on the LOQIC; GE Healthcare Technologies, Milwaukee, Wisconsin, United States). For each patient, AVF flows will be recorded by taking at least 3 measurements of AVF flow, at 2, 5, 10, and 15 cm proximal to the AVF anastomosis, and arithmetic averages will be calculated. AVF flow will be expressed in "ml/min".
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 5 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula, run by Kudret Atakan Tekin at 1 site in Turkey (Türkiye).
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 6 inclusion and 12 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
intraoperative Arteriovenous Fistula Flow Measurement (time frame: 1 hour). 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 5 Dec 2024.