Vein Histology in Arteriovenous Fistulas and Its Effect on Fistula Surgery Success
A Cohort Study of the Histopathological Changes Evident in Vein Wall at the Time of Arteriovenous Dialysis Access Fistulas and the Effects of Such Changes on Biomechanical Compliance and Patient's Clinical Outcomes in a University Teaching Hospital.
Patients whose kidneys have failed need to receive dialysis treatment, most commonly with a dialysis machine. In order to be connected to the machine an operation is often performed to join an artery to a vein in the arm. This forms what is known as an arteriovenous fistula. The fistula causes an increase in the flow of blood through the vein and the vein reacts to this by becoming bigger and thicker, making it easier to connect the patient to the machine.
The success rate for the operation is relatively low and only approximately 65 from every 100 operations is still working after a year. It is thought that one factor that may cause problems with the fistula is the ability of the vein to stretch in response to increased blood flow. Previous research has shown that veins in kidney failure patients look different to those of people whose kidneys are working when viewed under a microscope.
The investigators aim to study the structure of the vein that is used in making fistulas with a microscope and also to test it in an engineering laboratory to see how much it will stretch. The investigators hope that gaining information about the structure of the vein and its ability to stretch will help determine what it is about the vein that affects how well it works as part of a fistula. This information may help surgeons select the best possible vein in a given patient to give the best chance of a working fistula in the future.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Yorkshire
-
Hull、Yorkshire、イギリス、HU3 2JZ
- Academic Vascular Surgery Unit
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients referred to vascular consultants for AV fistula formation for haemodialysis access.
- Ability to give informed written consent
- Aged over 18 at time of referral
Exclusion Criteria:
- Veins identified on preoperative ultrasound scanning to be of a calibre too small to allow sufficient material to be obtained for biomechanical testing (<3mm diameter).
- Inability to give informed written consent
- Aged under 18 at time of referral
- Inability to attend follow-up appointments
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Observed cohort
All patients recruited.
Observed for clinical outcomes
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary failure of access - Immediate/early thrombosis or failure to mature.
時間枠:within 30 days of formation
|
Failure to mature or thrombosis of fistula
|
within 30 days of formation
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Duplex findings of evidence of stenosis and correlation to compliance or histological findings
時間枠:6 months
|
6 months
|
|
Correlation between biomechanical compliance and histological measures of pre existing venous pathology
時間枠:6 months
|
6 months
|
|
Correlation between biomechanical compliance testing and clinical outcomes
時間枠:6 months
|
6 months
|
|
Assisted primary and secondary patency rates at 3 and 6 months post fistula formation
時間枠:6 months
|
6 months
|
|
Functional primary patency
時間枠:6 months
|
6 months
|
協力者と研究者
捜査官
- 主任研究者:Ian C Chetter, MBChB FRCS、University of Hull
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。