Personalized Two-stage Regional Citrate Anticoagulation for CRRT in Patients With Citrate Metabolism Impairment (PRECISE)
Personalized Two-stage Regional Citrate Anticoagulation for CRRT in Patients With Citrate Metabolism Impairment: a Multicenter Randomized Controlled Study
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
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:
A. Aged 18 to 80 years, inclusive, male or female; B. Diagnosed with acute kidney injury or chronic kidney disease stage 5, and assessed by a physician as requiring continuous renal replacement therapy (CRRT); C. Citrate metabolism disorder, including liver failure (acute liver failure, acute-on-chronic liver failure, or decompensated cirrhosis), and/or microcirculation disorder (mean arterial pressure <65 mmHg requiring vasopressor therapy and lactate ≥2 mmol/L); D. The investigator determines that the patient can have a stable vascular access established (the access must be capable of providing a constant and effective blood flow rate >150 ml/min); E. The study participant (subject) and their legal guardian are able to understand the study purpose and provide written informed consent.
Exclusion Criteria:
A. Received regional citrate anticoagulation therapy within the previous 72 hours; B. Expected to require additional non-protocol calcium supplementation during CRRT due to disease-related needs; C. Requiring arterial-venous reversal of the extracorporeal circuit during CRRT due to poor flow; D. Requiring concurrent peritoneal dialysis during the trial period; E. Participated in or is currently participating in another clinical trial within 1 month prior to the date of signing the informed consent form; F. Expected survival time less than 72 hours; G. Any other conditions that, in the investigator's judgment, make the patient unsuitable for participation in the clinical trial.
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：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：コントロール
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The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.
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実験的：Two-stage
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The two-stage calcium supplementation refers to: the first stage after the initiation of CRRT, the amount of calcium supplementation includes the calcium clearance from the extracorporeal circuit and the accumulated calcium citrate in the body; when the blood citrate concentration reaches a steady state, the second stage begins, at which point the accumulated calcium is stable and only the calcium clearance from the extracorporeal circuit needs to be supplemented.
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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 |
|---|---|---|
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Intervention rate of iCa
時間枠：From 1 hour post-CRRT initiation to the end of CRRT
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During the CRRT iCa is measured at pre-set time points.
If the iCa concentration is either <0.95 or >1.35 mmol/L in the body, or <0.25 or >0.4 mmol/L in the extracorporeal circuit, it is defined as "iCa requiring intervention".
If both intracorporeal and extracorporeal iCa require intervention at the same time point, it is counted as two interventions.
Finally, the intervention rate of iCa is calculated.
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From 1 hour post-CRRT initiation to the end of CRRT
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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The filter failure rate and the causes of filter failure within 72 hours
時間枠：The first 72 hours of CRRT
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The first 72 hours of CRRT
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The differences and proportional distributions of in vivo and in vitro iCa values at each time point between the two groups
時間枠：From 1 hour post-CRRT initiation to the end of CRRT
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From 1 hour post-CRRT initiation to the end of CRRT
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The incidence of bleeding events, the bleeding-related blood transfusions, and the total volume of transfused blood
時間枠：From the initiation to the end of CRRT
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From the initiation to the end of CRRT
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The incidence of arrhythmias and neurological symptoms caused by abnormal iCa
時間枠：From 1 hour post-CRRT initiation to the end of CRRT
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From 1 hour post-CRRT initiation to the end of CRRT
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The incidence of hypocalcemia and hypercalcemia
時間枠：From 1 hour post-CRRT initiation to the end of CRRT
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From 1 hour post-CRRT initiation to the end of CRRT
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The incidence of metabolic acidosis and metabolic alkalosis
時間枠：From 1 hour post-CRRT initiation to the end of CRRT
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From 1 hour post-CRRT initiation to the end of CRRT
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The incidence of hypernatremia
時間枠：From 1 hour post-CRRT initiation to the end of CRRT
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From 1 hour post-CRRT initiation to the end of CRRT
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The incidence of clinically meaningful citrate accumulation
時間枠：From 1 hour post-CRRT initiation to the end of CRRT
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From 1 hour post-CRRT initiation to the end of CRRT
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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
追加の関連 MeSH 用語
その他の研究ID番号
- RCA-CRRT
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
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