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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

The purpose of this study is to compare the efficacy and safety of an individualized two-stage calcium supplementation method versus a conventional commercial RCA-CRRT module in RCA-CRRT for patients with citrate metabolism disorders.

研究概览

研究类型

介入性

注册 (估计的)

142

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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.
实验性的:Two-stage
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.

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
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
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
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
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

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月5日

初级完成 (估计的)

2028年2月14日

研究完成 (估计的)

2028年8月14日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月5日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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