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临床试验/NCT05216575
NCT05216575已完成不适用

Use of Almitrine in COVID-19 Patients With Acute Respiratory Distress Syndrome Treated by High-flow Nasal Canula Oxygen Therapy

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Almitrine-induced increase in Pa02/FiO2 ratio.

研究概览

简要总结

The purpose of this study is to determine the effects of Almitrine administration on oxygenation in COVID-19 patients with acute respiratory distress syndrome treated by high-flow nasal canula oxygen therapy as first-line ventilatory support.

详细描述

From December 2019, the emergent coronavirus SARSCoV-2 is responsible for the worldwide pandemic of coronavirus disease (COVID-19). Although SARSCoV-2 infection is mainly responsible for mild respiratory symptoms, up to 70% of hospitalized patients with COVID-19-related pneumoniae may develop severe respiratory disease, progressing to acute respiratory distress syndrome (ARDS). These patients may experience severe but well-tolerated hypoxemia, so-called "happy hypoxemia" which may be related to blunted hypoxic vasoconstriction. Almitrine is a selective pulmonary vasoconstrictor that has been reported to improve the oxygenation in ARDS patients by increasing hypoxic pulmonary vasoconstriction. Some small case series reported that the use of Almitrine in mechanically ventilated COVID-19 patients with ARDS improved oxygenation. Given the "happy hypoxemia" phenomenon, it has been suggested to use high-flow nasal canula therapy (HFNO) as first-line ventilatory support in COVID-19 patients with ARDS, since the risk of aerosolization with HFNO was similar to that with standard oxygen therapy and lower to that with non-invasive ventilation. However, the effects of Almitrine in spontaneously breathing patients with ARDS has not been reported so far. Thus, the main goal of this study is to investigate the effects of Almitrine on oxygenation of COVID-19 patients with ARDS treated by HFNO as first-line ventilatory support. The second goal of this study is to determine the effects of Almitrine on respiratory mechanics and hymodynamics.

研究设计

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

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 treated by high-flow nasal canula oxygen
  • Positive COVID-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs
  • Persistent severe hypoxemia after awake prone positioning defined by one or more of the following criteria:
  • SpO2 < 96% with FiO2 > 80%
  • PaO2/FiO2 ratio < 100 with FiO2 > 80%
  • Patients treated by Almitrine

排除标准

  • Age <18 years old and pregnant women
  • Patients under legal protection
  • Patients with a do not intubate or do not resuscitate decision
  • Patients requiring immediate invasive mechanical ventilation
  • Contraindication to Almitrine
  • Poor echogenicity

研究组 & 干预措施

Almitrine treated patients

Administration of Almitrine in spontaneoulsy breathing COVID-19 patients with moderate to severe ARDS treated by high-flow nasal canula oxygen therapy as first-line ventilatory support with persitent severe hypoxemia after awake prone positioning.

干预措施: Administration of Almitrine (Drug)

结局指标

主要结局

Almitrine-induced increase in Pa02/FiO2 ratio.

时间窗: The 30-minute duration of Almitrine bolus

The PaO2/FiO2 ratio will be calculated before and after the bolus of Almitrine. Patients with increase in PaO2/FiO2 ratio \> 20% will be considered as responders.

次要结局

  • Proportion of patients requiring intubation(ICU stay)
  • Clinical prediction of Almitrine effects(The 30-minute duration of Almitrine bolus)
  • Proportion of patients exhibiting right ventricular failure and/or right ventricular dilation and/or acute core pulmonale after administration of Almitrine.(The 30-minute duration of Almitrine bolus)
  • Radiological prediction of Almitrine effects(The 30-minute duration of Almitrine bolus)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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