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
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:控制
|
The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.
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实验性的: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intervention rate of iCa
大体时间:From 1 hour post-CRRT initiation to the end of CRRT
|
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.
|
From 1 hour post-CRRT initiation to the end of CRRT
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
The filter failure rate and the causes of filter failure within 72 hours
大体时间:The first 72 hours of CRRT
|
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
大体时间:From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
|
The incidence of bleeding events, the bleeding-related blood transfusions, and the total volume of transfused blood
大体时间:From the initiation to the end of CRRT
|
From the initiation to the end of CRRT
|
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The incidence of arrhythmias and neurological symptoms caused by abnormal iCa
大体时间:From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
|
The incidence of hypocalcemia and hypercalcemia
大体时间:From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
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The incidence of metabolic acidosis and metabolic alkalosis
大体时间:From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
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The incidence of hypernatremia
大体时间:From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
|
The incidence of clinically meaningful citrate accumulation
大体时间:From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- RCA-CRRT
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