跳至主要内容
临床试验/NCT06384287
NCT06384287招募中不适用

Effects of Therapeutic Hemodynamic Interventions on Peripheral Perfusion in Intensive Care

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
Skin blood flow variations

研究概览

简要总结

Tissue perfusion has been identified as an early prognosis factor in patients admitted to intensive care. However, little is known about the effects of different hemodynamic interventions performed in clinical routine on peripheral tissue perfusion.

The aim of this work is to study the kinetics of CRT and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug).

详细描述

Sepsis is today a major cause of morbidity and mortality worldwide. Septic shock, the most serious manifestation of the infection, affects 2 to 20% of intensive care patients. Despite appropriate antibiotic therapy and improved resuscitation strategies based on early treatment, volume expansion and rational use of vasopressors, the mortality rate of shock states remains too high, between 40 and 50%.

Over the past two decades, great advances have been made in the understanding the pathophysiology of septic shock. Microcirculatory abnormalities have been identified as the main cause of organ hypoperfusion and visceral failure leading to death. In addition, several studies in animals and humans have highlighted a discordance between systemic hemodynamic parameters and alterations of small vessels during shock suggesting that microvascular blood flow and tissue perfusion should be analyzed in patients with acute circulatory failure in association with blood pressure and cardiac output. Capillary refill time (CRT), is an easy-to-use, easy-to learn tool to evaluate peripheral tissue perfusion. CRT is a strong predictive factor of organ failure severity and poor outcome in critically ill patients with sepsis. A recent randomized trial reported promising results regarding the use of CRT to guide resuscitation. However, little is known about the impact of treatment on CRT. The aim of this work is to study the kinetics of CRT and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug).

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 in intensive care unit with acute circulatory failure related to sepsis or cardiac failure requiring therapeutic intervention

排除标准

  • Agitation
  • Hemorrhagic shock
  • Severe skin lesions

结局指标

主要结局

Skin blood flow variations

时间窗: continuous monitoring during 1 hour maximum starting just before intervention

Measurement using laser doppler probe in the finger tip

次要结局

  • Mottling score(at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes))
  • correlation between skin blood flow and Cardiac output(at baseline, at 10, 30 and 60 minutes after intervention)
  • Capillary refill time(at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes))
  • correlation between Skin blood flow and CRT (baseline and variations)(at baseline, at 10, 30 and 60 minutes after intervention)
  • correlation between skin blood flow and mean arterial pressure(at baseline, at 10, 30 and 60 minutes after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验