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Magnesium Kinetics During Citrate-Anticoagulated CRRT

2026年11月6日 更新者：Region Skane

Total and Ionized Magnesium Kinetics During Citrate-Anticoagulated Continuous Renal Replacement Therapy

The goal of this observational study is to assess how continuous renal replacement therapy (CRRT), a type of dialysis used in critically ill patients, affects magnesium levels in adults treated in intensive care units (ICUs). The study focuses on CRRT using citrate, a substance that prevents blood clotting in the dialysis circuit. Participants will receive CRRT with citrate as part of their routine medical care.

The main questions it aims to answer are:

How does citrate affect the amount of free (ionized) magnesium in the blood How much magnesium is removed by the dialysis circuit during treatment? How do magnesium levels in the blood change over time during treatment? How does treatment affect calcium and phosphate levels and what changes occur in the body's acid-base balance and metabolism?

Researchers will:

Measure magnesium, calcium and phosphate levels in blood and dialysis circuit fluid samples collected before and during treatment, for up to 72 hours.

Measure additional blood markers to assess changes in metabolism and acid-base balance.

Record dialysis treatment settings and fluid flow rates.

The collected measurements will be used to better understand how magnesium and other electrolytes are affected during CRRT with citrate.

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
尚未招聘

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

详细说明

Regional citrate anticoagulation (RCA) is frequently used during continuous renal replacement therapy (CRRT) to prevent blood clotting within the extracorporeal circuit. Citrate works by binding ionized calcium, thereby inhibiting the coagulation cascade. However, citrate also binds ionized magnesium, which may affect magnesium levels and contribute to magnesium losses during treatment. Previous studies have reported magnesium losses during CRRT with RCA but most have focused on total magnesium concentrations. The effects of citrate on ionized magnesium, the biologically active fraction of magnesium, remain less well understood.

The primary objective of this prospective observational study is to characterize magnesium kinetics during CRRT with RCA by repeated measurements of both total and ionized magnesium concentrations in the patient's blood and at different locations within the extracorporeal circuit. The study will investigate citrate-associated magnesium binding, magnesium transport across the dialysis filter, magnesium mass balance within the circuit and changes in systemic magnesium concentrations over time.

Secondary objectives are to characterize calcium and phosphate kinetics during treatment and to explore associated changes in acid-base balance and metabolic parameters.

Approximately 35 adult patients receiving CRRT with RCA as part of routine clinical care at three intensive care units (ICUs), one in Sweden and two in Iceland. Eligible patients will be those receiving continuous veno-venous hemodiafiltration (CVVHDF) using the PrisMax system and an ST150 hemofilter. All treatment decisions, including citrate administration, dialysis settings, and fluid management, will follow routine clinical practice and will not be altered by the study. Study-specific sampling will continue for up to 72 hours or until the ongoing CRRT circuit is discontinued, whichever occurs first.

Blood samples will be collected before treatment initiation and at 2, 6, 12, 18, 24, 48, and 72 hours after treatment begins. Systemic blood samples will be obtained from the patient's arterial line, while additional samples will be collected from the pre-filter and post-filter blood sampling ports and from the effluent fluid of the extracorporeal circuit. Total and ionized magnesium and calcium concentrations, as well as phosphate concentrations, will be measured to assess changes over time and calculate electrolyte transport and balance within the circuit. Additional systemic blood measurements will be performed before treatment and at 24, 48, and 72 hours to assess metabolic and acid-base responses. Dialysis treatment parameters, such as blood flow, citrate dose, treatment fluid flow rates and fluid removal, will also be recorded.

By combining repeated measurements of total and ionized magnesium with measurements across the extracorporeal circuit, this study aims to improve understanding of magnesium handling during CRRT with RCA. The findings may help determine whether monitoring total magnesium alone adequately reflects changes in ionized magnesium and provide further insight into electrolyte and metabolic changes during treatment.

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
观察性的

注册 (估计的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
35

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习联系方式

可以回答临床研究注册问题的人员的姓名和联系信息。进行研究的每个地点也可能有特定的联系人，他们可能能够更好地回答这些问题。

研究联系人备份

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

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population will consist of adult patients (≥18 years) admitted to the intensive care units (ICUs) at Skåne University Hospital in Sweden and Landspitali University Hospital in Iceland, for whom a clinical decision has been made to initiate continuous renal replacement therapy (CRRT) with regional citrate anticoagulation (RCA). Eligible patients will be those scheduled to receive continuous veno-venous hemodiafiltration (CVVHDF) using the PrisMax system and an ST150 hemofilter as part of routine clinical care.

描述

Inclusion Criteria:

  • Age ≥18 years.
  • Clinical decision to initiate continuous renal replacement therapy (CRRT) with regional citrate anticoagulation (RCA).
  • Planned treatment with continuous veno-venous hemodiafiltration (CVVHDF) using the PrisMax system and an ST150 hemofilter.
  • Informed consent obtained in accordance with the approved study procedures.

Exclusion Criteria:

- None beyond failure to meet the inclusion criteria.

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

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Changes in systemic total magnesium concentration
大体时间：Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.

Changes in systemic total magnesium concentration (mmol/L), measured using conventional clinical laboratory methods, will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation.
Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Changes in systemic ionized magnesium concentration
大体时间：Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.

Changes in systemic ionized magnesium concentration (mmol/L), measured using ion-selective electrode technology, will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation.
Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Citrate-associated changes in magnesium ionization
大体时间：At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.

Changes in the ionized magnesium fraction (ionized magnesium/total magnesium) between systemic and pre-filter blood will be assessed following administration of citrate-containing predilution fluid, accounting for dilution. Ionized magnesium will be measured using ion-selective electrode technology and total magnesium using conventional clinical laboratory methods.
At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Magnesium flux across the extracorporeal filter
大体时间：At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.

Magnesium flux across the extracorporeal filter (mmol/h) will be calculated using total and ionized magnesium concentrations in pre-filter and post-filter blood and effluent fluid, accounting for blood flow rates, treatment fluid flow rates and fluid composition. Ionized magnesium will be measured using ion-selective electrode technology and total magnesium using conventional clinical laboratory methods.
At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Net magnesium loss attributable to CRRT
大体时间：At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.

Net magnesium loss attributable to CRRT (mmol/h) will be calculated from magnesium removal in the effluent, accounting for magnesium supplied through dialysate and post-filter replacement fluids. Calculations will use the actual treatment fluid composition and flow rates at each sampling time. Ionized magnesium will be measured using ion-selective electrode technology and total magnesium using conventional clinical laboratory methods.
At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
Changes in systemic total calcium concentration
大体时间：Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.

Changes in systemic total calcium concentration (mmol/L), measured using conventional clinical laboratory methods, will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation.
Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Changes in systemic ionized calcium concentration
大体时间：Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.

Changes in systemic ionized calcium concentration (mmol/L), measured using ion-selective electrode technology, will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation.
Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Calcium flux across the extracorporeal filter
大体时间：At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.

Calcium flux across the extracorporeal filter (mmol/h) will be calculated using total and ionized calcium concentrations in pre-filter and post-filter blood and effluent fluid, accounting for blood flow rates, treatment fluid flow rates and fluid composition. Ionized calcium will be measured using ion-selective electrode technology and total calcium using conventional clinical laboratory methods.
At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Net calcium loss attributable to CRRT
大体时间：At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.

Net calcium loss attributable to CRRT (mmol/h) will be calculated from calcium removal in the effluent, accounting for calcium supplied through dialysate and post-filter replacement fluids. Calculations will use the actual treatment fluid composition and flow rates at each sampling time. Ionized calcium will be measured using ion-selective electrode technology and total calcium using conventional clinical laboratory methods.
At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Changes in systemic phosphate concentration
大体时间：Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.

Changes in systemic phosphate concentration (mmol/L), measured using conventional clinical laboratory methods, will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation.
Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Phosphate flux across the extracorporeal filter
大体时间：At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.

Net phosphate flux across the extracorporeal filter (mmol/h) will be calculated using phosphate concentrations measured by conventional clinical laboratory methods in pre-filter and post-filter blood and effluent fluid, accounting for blood and treatment fluid flow rates and fluid composition.
At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Net phosphate loss attributable to CRRT
大体时间：At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.

Net phosphate loss attributable to CRRT (mmol/h) will be calculated using phosphate concentrations measured in effluent fluid by conventional clinical laboratory methods, accounting for phosphate supplied through dialysate and replacement fluids. Calculations will use the actual treatment fluid composition and flow rates at each sampling time.
At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Changes in systemic blood pH during RCA-CRRT
大体时间：Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.

Changes in systemic arterial blood pH will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation, using arterial blood gas analysis.
Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Changes in systemic bicarbonate concentration during RCA-CRRT
大体时间：Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.

Changes in systemic bicarbonate concentration (mmol/L) will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation, using arterial blood gas analysis.
Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Changes in systemic base excess during RCA-CRRT
大体时间：Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.

Changes in systemic base excess (mmol/L) will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation, using arterial blood gas analysis.
Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.

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。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
Region Skane

合作者

合作者

为临床研究提供支持的赞助商以外的组织。这种支持可能包括与资金、设计、实施、数据分析或报告相关的活动。
Nova Biomedical
Vantive Health LLC

调查人员

调查人员

参与临床研究的研究人员。相关术语包括中心首席研究员、中心副研究员、研究主席、研究主管和研究首席研究员。
  • 首席研究员：Marcus Ewert Broman、Skåne University Hospital, Lund University

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)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2026年11月1日

初级完成 (估计的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2027年10月1日

研究完成 (估计的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2028年1月1日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2026年10月23日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年10月23日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2026年10月30日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年11月12日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年11月6日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年11月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • Dnr 2025-08131-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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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