Identifying Risk Factors (RF) for Early Haemodialysis Arteriovenous Fistula Failure (eAVFF)

NCT05552482 | Completed

• 1 other identifier: 2022-06Obs-CHRMT
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Arteriovenous fisutla (AVF) is the vascular access of choice for hemodialysis but has a high early failure (eAVFF) rate. eAVFF can be defined as thrombosis/stenosis and Doppler ultrasound (DUS)-based failure-to-mature parameters such as postoperative blood flow (PostQa) \< 500 ml/min, AVF-vein diameter (PostVD) \< 5 mm, and AVF-vein depth (PostVDepth) ≥ 6 mm. We explored whether common risk factors for eAVFF could predict these eAVFF parameters and venous distensibility: the latter is largely overlooked as a potential eAVFF parameter.

Conditions

Arteriovenous Fistula; Hemodialysis; End Stage Chronic Renal Failure

Outcome Measures

Primary Outcomes (1)

• Identification of the pre/perioperative factors that predict early AVF failure (eAVFF)

  Comparison of preoperative and intraoperative results according to composite factors of arteriovenous fistula failure: Qa blood flow \< 500 ml/min, postoperative venous internal diameter PostVD \< 5 mm; complications: presence of stenosis, presence of thrombosis; AVF vein depth (external diameter) (PostVDepth) ≥ 6. The following variables were compared between groups: age (years) , sex (Man/Women), body mass index (kg/m2), Comorbidities \[Diabetes mellitus (yes/no), obesity (yes/no)\], Preoperative hemoglobin (g/dl); locoregional anesthesia (yes/no), Central Venous Catether (CVC) use (yes/no); CVC use on same side as AVF (yes/no); AVF on left side of body (yes/no); Distal AVF location (yes/no); Preop AVF vessel diameter (artery and vein; mm).

  up to 3 months after AVF creation

Secondary Outcomes (4)

• Identification of the pre/perioperative factors that predict the early postoperative AVF blood flow (PostQa)

  up to 3 months after AVF creation

• Identification of the pre/perioperative factors that predict the early postoperative venous internal diameter (PostVD)

  up to 3 months after AVF creation

• Identification of the pre/perioperative factors that predict the early postoperative AVF stenosis and/or thrombosis

  up to 3 months after AVF creation

• Identification of the pre/perioperative factors that predict the early postoperative skin to AVF distance

  up to 3 months after AVF creation

Study Arms (2)

Patients with ESRD with early AVF failure

Patients with ESRD who underwent AVF access creation surgery with early AVF failure

Other: Identification of predictive factors

patients with ESRD without early AVF failure

Patients with ESRD who underwent AVF access creation surgery without early AVF failure

Other: Identification of predictive factors

Interventions

Identification of predictive factors OTHER

Evaluation of the following variables : age, sex, body mass index, Diabetes mellitus, vascular disease, hematologic disease, venous thromboembolic disease, antiplatelet or anticoagulant treatments, haemodialysis Catheter Insertion, number of comorbid conditions, Venous diameter, Arterial diameter, AVF type, AVF limb, Anasthesia group

Patients with ESRD with early AVF failure; patients with ESRD without early AVF failure

Eligibility Criteria

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

Study Population

Adult patients (≥ 18 years) who had undergone distal (radioradial and radiocephalic) and proximal arteriovenous fistula (AVF) access creation surgery

You may qualify if:

• Adult patients (≥ 18 years)
• Patients who had undergone distal (radioradial and radiocephalic) or proximal arteriovenous fistula (AVF) access creation surgery between 2016 and 2021 at the CHR Metz-Thionville.
• Patients who underwent preoperative and postoperative Doppler ultrasound (DUS) ≤ 4 months after surgery.
• Patients with central venous catheter (CVC) at surgery

You may not qualify if:

• Patients using the fistula for intermittent plasmapheresis
• Patients with a radiobasilic AVF or arteriovenous graft

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Renal Insufficiency, Chronic

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; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Zead TUBAIL, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: January 5, 2021
• Primary Completion: October 5, 2021
• Study Completion: December 21, 2022
• Last Updated: March 10, 2023

Record last verified: 2023-02

Locations

FR (1)