跳至主要内容
临床试验/NCT07837843
NCT07837843尚未招募不适用

Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL)

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Assessment of the ability of fluid challenge-induced changes in capillary refill time to predict fluid challenge-induced changes in oxygen consumption

研究概览

简要总结

Circulatory shock is characterized by tissue hypoxia. Although fluid resuscitation is an essential treatment in many forms of circulatory shock, its benefits are variable, and its administration carries a risk of potentially harmful fluid overload.

Assessment of fluid responsiveness generally relies on changes in cardiac output. However, the actual therapeutic objective is rather to improve tissue oxygen utilization, as reflected by oxygen consumption. Despite its physiological relevance, direct measurement of oxygen consumption remains complex and difficult to perform in routine clinical practice.

Capillary refill time is a simple, rapid, non-invasive, and readily available marker of peripheral perfusion. It is associated with outcomes in patients with circulatory shock, and a capillary refill time-guided therapeutic strategy may improve outcomes in patients with septic shock.

This study hypothesizes that changes in capillary refill time following fluid resuscitation may predict changes in oxygen consumption induced by fluid administration. If confirmed, capillary refill time and its changes could be incorporated into the criteria used to assess the indication for fluid resuscitation in patients with shock. They would also provide additional physiological information regarding the relationship between peripheral perfusion and oxygen consumption.

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
否

入选标准

  • •Adult patient admitted to the intensive care unit within the previous 72 hours
  • •Receiving invasive mechanical ventilation
  • •For whom the clinician plans to perform a fluid challenge
  • •No objection from the participant or a relative/legally authorized representative

排除标准

  • •Fraction of inspired oxygen greater than 60%
  • •Administration of inhaled medications, including nitric oxide
  • •Positive end-expiratory pressure greater than 15 cmH₂O
  • •Excessive leaks in the ventilator circuit, defined as an expired volume less than 95% of the inspired volume
  • •Patient receiving mechanical circulatory support involving a gas exchanger
  • •Patient receiving renal replacement therapy
  • •Administration of sodium bicarbonate within the 2 hours preceding inclusion
  • •Disconnection from the ventilator anticipated before the end of the study

研究组 & 干预措施

Patients

The patients targeted by this study are mechanically ventilated intensive care patients for whom the attending clinician plans to perform a fluid challenge.

干预措施: Indirect calorimetry measurement (Device)

结局指标

主要结局

Assessment of the ability of fluid challenge-induced changes in capillary refill time to predict fluid challenge-induced changes in oxygen consumption

时间窗: Day 0

Area under the receiver operating characteristic curve of changes in capillary refill time for predicting a 15% increase in oxygen consumption during a fluid challenge

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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