- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06262659
The Effect of Ultrasonography on Blood Flow,Vessel Diameter,and Depth Measurements in Dialysis Patients With Fistula
Effect Of Blood Flow, Vascular Diameter, And Depth Measurements With Intraoperative Doppler Ultrasonography On Arteriovenous Fistula Maturation In Dialysis Patients: A Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kudret Atakan Tekin
- Phone Number: +905424912184
- Email: dr.kudretatakantekin@gmail.com
Study Locations
-
-
Çorum
-
Merkez, Çorum, Turkey
- Recruiting
- Kudret Atakan Tekin
-
Contact:
- Kudret Atakan Tekin
- Phone Number: 05424912184
- Email: dr.kudretatakantekin@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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".
|
1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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