Almitrine and COVID-19 Related Hypoxemia
关键词
抽象
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.
日期
| 最后验证: | 04/30/2020 |
| 首次提交: | 04/27/2020 |
| 提交的预估入学人数: | 05/06/2020 |
| 首次发布: | 05/07/2020 |
| 上次提交的更新: | 05/06/2020 |
| 最近更新发布: | 05/07/2020 |
| 实际学习开始日期: | 03/19/2020 |
| 预计主要完成日期: | 04/13/2020 |
| 预计完成日期: | 04/24/2020 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Almitrine Administration of 4 mcg/kg/min iv almitrine bismesylate (Vectarion®, Servier Laboratory, France), over 30-45 min followed by 12 mcg/kg/min infusion rate. Because of a shortage of drug store at national level, a protocol using continuous infusion was not considered. Some patients may receive the drug for 36 hours depending on availability.. | |
| Control To eliminate the eventuality of a spontaneous evolution of hypoxia, these patients were matched to control COVID-19 patients treated without almitrine (time control). |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria : - a positive RT- PCR, - a highly suggestive thoracic CTScan, and - a severe hypoxemia leading to intubation for less than 3 days - mechanically ventilated at FiO2 1 with a severe intrapulmonary shunt during their early phase Group : patient who has been treated with almitrine (4 mcg/kg/min iv almitrine bismesylate (Vectarion®, Servier Laboratory, France) then 12 mcg/kg/min infusion rate) during their hospital treatment. Control group : Matched COVID-19 patients, on gender, age, BMI and duration of mechanical ventilation, with serial measurements corresponding to the duration of almitrine testing (8 hours), with same inclusion and exclusion criteria. Exclusion Criteria: - the presence of an acute cor-pulmonale on the trans-thoracic 2D Echo-Doppler - abnormal liver function tests - hyperlactatemia |
结果
主要结果指标
1. Changes from baseline PaO2 (mmHg) [45 minutes after almitrine infusion]
2. Changes from baseline ScvO2 (%) [baseline and 45 minutes after almitrine infusion]
次要成果指标
1. Changes from baseline PaO2 (mmHg) [8 hours]
2. Changes from baseline ScvO2 (%) [8 hours]
