Comparison of Citrate and Heparin Anticoagulation During Postdilution Hemodiafiltration (CITRA-HDF)
Efficiency and Biocompatibility of Postdilution Hemodiafiltration Using Different Anticoagulation Methods: A Randomized Crossover Clinical Trial
This randomized crossover clinical trial will compare regional citrate anticoagulation (RCA) and standard heparin anticoagulation (HA) during postdilution hemodiafiltration (HDF) in chronic dialysis patients with end-stage kidney disease.
The primary aim of the study is to evaluate biocompatibility during HDF by measuring markers of complement activation (C3a), platelet activation (PF4), and coagulation activation (thrombin-antithrombin complex, TAT).
Secondary aims include comparison of solute removal efficiency, including beta-2 microglobulin, phosphate, and urea removal, as well as assessment of citrate, calcium, and magnesium kinetics during citrate anticoagulation.
Twenty adult chronic dialysis patients will undergo two study HDF procedures in randomized order: one procedure using heparin anticoagulation and one procedure using regional citrate anticoagulation with a one-week interval between procedures.
The study aims to improve understanding of the effects of anticoagulation methods on hemodiafiltration biocompatibility and dialysis efficiency and may contribute to optimization of citrate anticoagulation protocols in chronic hemodiafiltration patients.
調査の概要
状態
詳細な説明
Hemodiafiltration (HDF) is an advanced renal replacement therapy combining diffusion and convection, allowing improved removal of middle and larger molecular weight solutes compared with standard hemodialysis. During extracorporeal circulation, blood contact with artificial membranes and tubing activates complement, platelets, leukocytes, and coagulation pathways, requiring anticoagulation during the procedure.
Unfractionated heparin is routinely used for anticoagulation during HDF. Regional citrate anticoagulation (RCA) is mainly used in patients at increased bleeding risk. Previous studies in hemodialysis have suggested that citrate anticoagulation may improve biocompatibility because many blood-material interactions are calcium- and magnesium-dependent. However, biocompatibility during HDF using citrate versus heparin anticoagulation has not been systematically investigated.
This prospective randomized crossover clinical trial will include 20 adult patients with end-stage kidney disease receiving maintenance postdilution hemodiafiltration three times weekly. Patients will be randomized to one of two anticoagulation sequences: heparin-citrate or citrate-heparin. Each participant will undergo two study HDF procedures separated by a one-week interval.
During heparin anticoagulation, unfractionated heparin will be administered according to body weight using standard clinical protocols. During citrate anticoagulation, 8% trisodium citrate infusion and calcium-free dialysate will be used, with continuous calcium chloride substitution adjusted according to ionized calcium levels.
Biocompatibility markers including complement activation marker C3a, platelet factor 4 (PF4), thrombin-antithrombin complex (TAT), blood cell counts, and coagulation parameters will be assessed before HDF, after 15 minutes, and at the end of the procedure.
Dialysis efficiency will be evaluated by measurement of reduction ratios and total removal of beta-2 microglobulin, phosphate, and urea using partial dialysate collection methodology.
Additional secondary outcomes include assessment of citrate, calcium, and magnesium kinetics during RCA-HDF, visual clotting score evaluation of the extracorporeal circuit, and optimization of citrate anticoagulation protocols during postdilution HDF.
The study may contribute to improved understanding of anticoagulation-related biocompatibility during HDF and support wider evidence-based use of regional citrate anticoagulation in chronic dialysis patients.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Milena MD Andonova
- 電話番号：+38615228123
- メール：milena.andonova@kclj.si
研究場所
-
-
-
Ljubljana、スロベニア、1000
- University Medical Centre Ljubljana
-
コンタクト：
- Milena MD Andonova
- 電話番号：+38615228123
- メール：milena.andonova@kclj.si
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18 years or older
- End-stage kidney disease requiring maintenance postdilution hemodiafiltration
- Stable chronic hemodialysis treatment three times weekly
- Functional arteriovenous fistula
Exclusion Criteria:
- Therapeutic anticoagulation therapy
- Dual antiplatelet therapy
- Significant coagulopathy
- Active bleeding
- Acute kidney injury
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Citrate anticoagulation
Participants will undergo postdilution hemodiafiltration using regional citrate anticoagulation with 8% trisodium citrate infusion and calcium substitution according to ionized calcium measurements
|
Regional citrate anticoagulation using 8% trisodium citrate infusion during postdilution hemodiafiltration with calcium substitution adjusted according to ionized calcium levels.
|
|
アクティブコンパレータ：Heparin anticoagulation
Participants will undergo postdilution hemodiafiltration using standard unfractionated heparin anticoagulation according to routine clinical protocol.
|
Standard unfractionated heparin anticoagulation administered according to routine clinical protocol during postdilution hemodiafiltration.
|
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 |
|---|---|---|
|
Biocompatibility markers (C3a, PF4, TAT)
時間枠：Before hemodiafiltration, after 15 minutes of treatment, and immediately before the end of the procedure.
|
Comparison of complement activation marker C3a, platelet factor 4 (PF4), and thrombin-antithrombin complex (TAT) concentrations between citrate and heparin anticoagulation during postdilution hemodiafiltration.
|
Before hemodiafiltration, after 15 minutes of treatment, and immediately before the end of the procedure.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Beta-2 microglobulin removal
時間枠：Before, after 30 minutes and at the end of the procedure hemodiafiltration procedure.
|
Reduction ratio and total removal of beta-2 microglobulin during hemodiafiltration.
|
Before, after 30 minutes and at the end of the procedure hemodiafiltration procedure.
|
|
instantaneous urea clearance after 30 minutes
時間枠：after 30 minutes of dialysis
|
instantaneous urea clearance after 30 minutes
|
after 30 minutes of dialysis
|
|
p-cresyl sulfat removal
時間枠：P-cresyl sulfat removal before, during and to the end of procedure
|
P-cresyl sulfat removal before, after 30 minutes and at the end of the procedure
|
P-cresyl sulfat removal before, during and to the end of procedure
|
|
Ionized calcium kinetics
時間枠：During the 4-hour hemodiafiltration procedure
|
During citrate anticoagulation procedure
|
During the 4-hour hemodiafiltration procedure
|
|
Extracorporeal circuit clotting score
時間枠：At the end of hemodiafiltration procedure.
|
At the end of hemodiafiltration procedure.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- BIOCOMP-HDF
- 0120-610/2025-2711-5 (レジストリ識別子：Republic of Slovenia National Medical Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。