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临床试验/NCT04380727
NCT04380727已完成不适用

Almitrine and Severe COVID-19 Patients in ICU [Almitrine et Patients COVID-19 en Reanimation (French)]

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2020年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
1
主要终点
Changes from baseline ScvO2 (%)

研究概览

简要总结

In severe COVID-19 pulmonary failure, the profound hypoxemia is mainly related to pulmonary vasodilation with altered hypoxic pulmonary vasoconstriction (HPV). Besides prone positioning, other non-ventilatory strategies may reduce the intrapulmonary shunt. This study has investigated almitrine, a pharmacological option used in standard care to improve oxygenation.

A case control series of mechanically ventilated confirmed COVID-19 patients was recorded.

At stable ventilatory settings, consecutive patients received two doses of almitrine (4 and 12 mcg/kg/min) at 30-45 min interval each, and were compared to 7 "control" COVID-matched patients conventionally treated.

The end-point was the reduction of intra-pulmonary shunt, with an increase in partial pressure of arterial oxygen (PaO2) and central venous oxygen saturation (ScvO2).

详细描述

The clinical presentation of COVID-19 disease is heterogenous, ranging from no symptoms to severe acute respiratory failure (ARF), which may have a poor prognosis. A severe hypoxemia is associated with preserved respiratory mechanical properties, in particular the pulmonary system compliance.

The hypoxia during the early phase seems to mainly result from an important ventilation/perfusion (VA/Q) mismatch associated with an altered pulmonary vasoconstriction. The "protective" mechanism called hypoxic pulmonary vasoconstriction (HPV) normally reduces the blood flow in poorly or non-ventilated areas towards aerated zones leading to reduce the (VA/Q) mismatch. HPV seems poorly functional in COVID-19 severe patients in absence of "cor pulmonale".

According to the French National agency for Drug Security (ANSM, Paris, France), only iv almitrine is indicated for hypoxic acute respiratory failure as Drug of Major Therapeutic Interest. This molecule is a routine option in the treatment strategy of severe hypoxemia.

The investigators studied COVID-19 patients mechanically ventilated at FiO2 1 with a severe intrapulmonary shunt during their early phase. The emergency conditions and the acute high inflow of patients to ICU impeded the design of a randomized control trial. To eliminate the eventuality of a spontaneous evolution of hypoxia, these patients will be compared with control-matched COVID patients treated conventionally.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • 未提供

排除标准

  • the presence of an acute cor-pulmonale on the trans-thoracic 2D Echo-Doppler
  • abnormal liver function tests
  • hyperlactatemia

结局指标

主要结局

Changes from baseline ScvO2 (%)

时间窗: baseline and 45 minutes after almitrine infusion

central venous oxygen saturation

Changes from baseline PaO2 (mmHg)

时间窗: 45 minutes after almitrine infusion

Partial pressure of oxygen in arterial blood

次要结局

  • Changes from baseline PaO2 (mmHg)(8 hours)
  • Changes from baseline ScvO2 (%)(8 hours)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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