Almitrine in COVID-19 Patients With ARDS Treated by HFNO

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Recruiting
CT.gov ID
NCT05216575
Collaborator
(none)
50
1
14.9
3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Administration of Almitrine

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Use of Almitrine in COVID-19 Patients With Acute Respiratory Distress Syndrome Treated by High-flow Nasal Canula Oxygen Therapy
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Administration of Almitrine
Administration of Almitrine (intravenous bolus of 0.5 mg/kg over 30 minutes followed by a continuous perfusion of 16 mg/kg/min in responders)

Outcome Measures

Primary Outcome Measures

  1. Almitrine-induced increase in Pa02/FiO2 ratio. [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.

Secondary Outcome Measures

  1. Proportion of patients requiring intubation [ICU stay]

    To assess the proportion of patients who will require to be intubated during their ICU stay.

  2. 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]

    To assess the proportion of patients who will experience right ventricular failure and/or right ventricular dilation and/or acute core pulmonale after administration of Almitrine.

  3. Clinical prediction of Almitrine effects [The 30-minute duration of Almitrine bolus]

    To test the ability of different respiratory variables and radiological patterns to predict the response to Almitrine in terms of oxygenation

  4. Radiological prediction of Almitrine effects [The 30-minute duration of Almitrine bolus]

    To test the ability of different radiological patterns to predict the response to Almitrine in terms of oxygenation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients treated by high-flow nasal canula oxygen

  2. Positive COVID-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs

  3. Persistent severe hypoxemia after awake prone positioning defined by one or more of the following criteria:

  4. SpO2 < 96% with FiO2 > 80%

  5. PaO2/FiO2 ratio < 100 with FiO2 > 80%

  6. Patients treated by Almitrine

Exclusion Criteria:
  1. Age <18 years old and pregnant women

  2. Patients under legal protection

  3. Patients with a do not intubate or do not resuscitate decision

  4. Patients requiring immediate invasive mechanical ventilation

  5. Contraindication to Almitrine

  6. Poor echogenicity

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de NICE Nice France 06200

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT05216575
Other Study ID Numbers:
  • 22reamedcovid01
First Posted:
Jan 31, 2022
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2022