The Effect of Ultrasonography on Blood Flow,Vessel Diameter,and Depth Measurements in Dialysis Patients With Fistula

NCT06262659 | Completed

• 1 other identifier: 2023-142
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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%. 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.

Conditions

Arteriovenous Fistula

Keywords

arteriovenous fistula; fistula flow; vascular diameter; intraoperative Doppler Ultrasound; arteriovenous fistula maturation

Outcome Measures

Primary Outcomes (1)

• 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".

  1 hour

Study Arms (1)

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.

Other: Doppler Ultrasonography Assessment

Interventions

Doppler Ultrasonography Assessment OTHER

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.

group fistula

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing the first-time autologous arteriovenous fistula creation surgery in end-stage renal failure will be included in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kudret Atakan Tekin: lead

Study Sites (1)

Kudret Atakan Tekin

Merkez, Çorum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 16, 2024
• Study Start: March 8, 2024
• Primary Completion: June 10, 2024
• Study Completion: September 10, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)