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临床试验/NCT07428395
NCT07428395Enrolling By Invitation不适用

Feasibility of Intradialytic Hematocrit and Oxygen Saturation Monitoring During Continuous Kidney Replacement Therapy

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
1
主要终点
Accuracy (% deviation) of hematocrit measured by CLM (Hct CLM) and hematocrit as measured by complete blood count (Hct CBC).

研究概览

简要总结

This is a pilot observational cohort study to understand whether advanced monitoring techniques can be applied during continuous kidney replacement therapy (CKRT), which is the most common form of dialytic therapy provided in critically ill patients.

详细描述

The CritLine-IV® monitor is a non-invasive device which integrates into the dialysis circuitry to continuous provide hematocrit and oxygen saturation values during dialysis. This monitoring has been used both in clinical and research settings with good accuracy over 4 hours of hemodialysis and has been used to guide real-time decisions on fluid management during intermittent hemodialysis. Given its non-invasive application, continuous measurements, and ease of integration into the dialysis circuitry, this technology has great potential for use in the critical care setting, where changes in clinical status and acuity of illness often require frequent reassessment and adjustment of dialysis settings. However, the reliability of Critline-IV® measurements over longer periods of time is unknown. In this study, we intend to determine the accuracy over time of Critline-IV® monitoring during CKRT, establish whether it impacts CKRT performance (primarily dialysis filter patency), and explore potential signal changes during various interventions commonly performed in the intensive care unit.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have been admitted to the Medical ICU or Cardiothoracic ICU at the Hospital of the University of Pennsylvania (HUP).
  • Patients who have been prescribed continuous venovenous hemodialysis (CVVHD) or Continuous Veno-Venous Hemofiltration (CVVH), the predominant modalities of continuous kidney replacement therapy (CKRT) at HUP.
  • Patients who have central venous catheters placed in either the left or right internal jugular veins.

排除标准

  • Patients who are prescribed other forms of CKRT, namely continuous venovenous hemofiltration (CVVH), slow continuous ultrafiltration (SCUF), or prolonged intermittent kidney replacement therapy (PIKRT).
  • Patients who have femoral vein dialysis catheters placed.
  • Patients who cannot provide consent or have a legal proxy to provide consent.

结局指标

主要结局

Accuracy (% deviation) of hematocrit measured by CLM (Hct CLM) and hematocrit as measured by complete blood count (Hct CBC).

时间窗: 48-hour dialysis treatment

次要结局

  • Accuracy (% deviation) oxygen saturated measured by CLM (SpO2 CLM) and oxygen saturation as measured by complete blood count (SpO2 VBG)(48-hour dialysis treatment)
  • Time of patency of the NxStage-CritLine cartridge/filter system(48-hour dialysis treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christina Brotman

Assistant Professor

University of Pennsylvania

研究点 (1)

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