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临床试验/NCT07240103
NCT07240103已完成不适用

Blood-Interstitial Fluid Glucose Gap: A Novel Indicator for Assessing Metabolic Status and Mortality Risk in Critically Ill Patients

Chinese Medical Association1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年7月13日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
ICU Mortality

研究概览

简要总结

Metabolic monitoring is fundamental to guiding nutritional therapy in critically ill patients. Although indirect calorimetry is the established gold standard for measuring resting energy expenditure, its routine clinical use is constrained by practical challenges, including procedural complexity, time-intensive nature, significant cost, and limited feasibility in patients on advanced life support, such as extracorporeal membrane oxygenation (ECMO). Dysregulation of glucose metabolism is common in this population, characterized not only by absolute dysglycemia but also-and perhaps more critically-by impairments in the efficiency of glucose transport and utilization across the microcirculatory continuum (from arterial blood, through the interstitial space, to venous return). This study seeks to examine the relationship between novel dynamic metrics-such as the arterio-interstitial glucose gradient-and key clinical parameters, including energy expenditure, organ function, and patient outcomes. Our objective is to assess the utility of these measures as minimally invasive, real-time biomarkers of metabolic state in critical illness.

详细描述

This prospective observational study aims to investigate the association between blood-interstitial fluid glucose concentration differences and resting energy expenditure, organ function, and clinical outcomes in critically ill patients, while also exploring potential factors influencing these glucose concentration differences.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age≥ 18 years and < 80 years
  • ICU stay ≤48 hours
  • Expected ICU stay > 24 hours
  • APACHE II score≥ 8

排除标准

  • local infection within the sensor placement area
  • Laparotomy within lower abdomen
  • Participated in this study before
  • In other clinical trails

结局指标

主要结局

ICU Mortality

时间窗: From date of study enrollment until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 60 days

The incidence of all-cause death during the patient's stay in the Intensive Care Unit

次要结局

  • Duration of Vasopressor Dependency(From date of study enrollment until the date of vasopressor cessation for at least 24 hours, assessed up to 30 days)
  • Duration of Invasive Mechanical Ventilation(From date of study enrollment until the date of successful extubation, tracheostomy, or death from any cause, whichever came first, assessed up to 30 days)
  • Duration of Continuous Renal Replacement Therapy (CRRT)(From date of study enrollment until the date of CRRT discontinuation for at least 24 hours or death from any cause, whichever came first, assessed up to 30 days)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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