Status:

COMPLETED

Almitrine and COVID-19 Related Hypoxemia

Lead Sponsor:

Central Hospital, Nancy, France

Conditions:

COVID-19

Hypoxic Respiratory Failure

Eligibility:

All Genders

18+ years

Brief Summary

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-ven...

Detailed Description

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 wit...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 20 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    April 25 2020

    Estimated Enrollment :

    17 Patients enrolled

    Trial Details

    Trial ID

    NCT04380727

    Start Date

    March 20 2020

    End Date

    April 25 2020

    Last Update

    July 30 2020

    Active Locations (1)

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    1

    Centre Hospitalier Universitaire NANCY

    Vandœuvre-lès-Nancy, France, 54511