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NCT Number: NCT05552482

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

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.

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Key information

Conditions

Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes End Stage Chronic Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Hemodialysis Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: up to 3 months after AVF creation

    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).

Secondary outcomes

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

    Time frame: up to 3 months after AVF creation

    Comparison of preoperative and intraoperative results according to AVF blood flow (Qa < 500 ml/min) for the following variables: age (years) , sex (Man/Women), body mass index (kg/m2), Diabetes mellitus (yes/no), vascular disease (yes/no), hematologic disease (yes/no), venous thromboembolic disease (yes/no), antiplatelet or anticoagulant treatments (yes/no), haemodialysis Catheter Insertion (yes/no), the number of comorbid conditions (1, 2, 3 and 4), Venous diameter (mm), Arterial diameter (mm), AVF type (Brachiocephalic/Radiocephalic), AVF limb (left/right), Anasthesia group (local/general)

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

    Time frame: up to 3 months after AVF creation

    Comparison of preoperative and intraoperative results according to venous internal diameter (PostVD < 5 mm vs > 5 mm) for the following variables: age (years) , sex (Man/Women), body mass index (BMI: kg/m2), Comorbidities (Diabetes mellitus (yes/no), vascular disease (yes/no), hematologic disease (yes/no), venous thromboembolic disease (yes/no), antiplatelet or anticoagulant treatments (yes/no), haemodialysis Catheter Insertion (yes/no), the number of comorbid conditions (1, 2, 3 and 4), Venous diameter (mm), Arterial diameter (mm), AVF type (Brachiocephalic/Radiocephalic), AVF limb (left/right), Anasthesia group (local/general)

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

    Time frame: up to 3 months after AVF creation

    Comparison of preoperative and intraoperative results according to stenosis and/or thrombosis (stenosis or thrombosis vs no complications) for the following variables: age (years) , sex (Man/Women), body mass index (kg/m2), Diabetes mellitus (yes/no), vascular disease (yes/no), hematologic disease (yes/no), venous thromboembolic disease (yes/no), antiplatelet or anticoagulant treatments (yes/no), haemodialysis Catheter Insertion (yes/no), the number of comorbid conditions (1, 2, 3 and 4), Venous diameter (mm), Arterial diameter (mm), AVF type (Brachiocephalic/Radiocephalic), AVF limb (left/right), Anasthesia group (local/general)

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

    Time frame: up to 3 months after AVF creation

    Comparison of preoperative and intraoperative results according to skin-AVF distance (< 6 mm vs ≥ 6 mm) for the following variables: age (years) , sex (Man/Women), body mass index (kg/m2), Diabetes mellitus (yes/no), vascular disease (yes/no), hematologic disease (yes/no), venous thromboembolic disease (yes/no), antiplatelet or anticoagulant treatments (yes/no), haemodialysis Catheter Insertion (yes/no), the number of comorbid conditions (1, 2, 3 and 4), Venous diameter (mm), Arterial diameter (mm), AVF type (Brachiocephalic/Radiocephalic), AVF limb (left/right), Anasthesia group (local/general)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

Identification of Factors That Predict Early Haemodialysis Arteriovenous Fistula Failure

Acronym: eAVFF-RF

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 23, 2022
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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